[Webinar] How to Address an FDA 483 Warning Letter with John Waters



hello everybody and welcome to wit mixes webinar how to address an FDA 43 warning letter with mr. John waters my name is Craig Pinkett I'm the education manager here for wit mix corporation and I will be facilitating today's webinar I'd like to begin with a few housekeeping items and first of all in the upper right hand corner of your screen you should see a questions box please feel free to type in any questions you have throughout the webinar and John will be answering your questions at the end next if you're a CDT this webinar is approved for one hour of C credit toward your certification in regulatory standards you will receive an email within one to two days it'll tell you how to obtain that credit and lastly this webinar is being recorded and within 48 hours it will be up on the wit Mix website in the webinar section which is a top of the page on our homepage now by way of introduction this morning I have the pleasure of introducing to you John Waters John is the regulatory compliance officer for whip mix John has worked in some regulatory capacity for most of his career he has represented his employers at the local state and regional areas related to Environmental Protection Agency metropolitan Sewer District Occupational Safety Health Administration and the Food and Drug Administration John spent the last seven years in medical device related endeavors and because of his firsthand FDA experience he understands quality system regulations or Q SR and he understands those from the agency's perspective John's extensive experience with the FDA includes some of these areas 21 CFR part 820 device sterility and sterilization by 10k submissions medical device reports international FDA inspections warning letter resolution device classification and company classification verification and validation risk management recalls advisory notices and market withdrawals so you can see the John has quite an in-depth background this webinar this morning is intended to address when and how to address FDA warning letters for device deficiencies and with that John let's talk about those warning letters thank you very much Craig before that glowing introduction first of all I would like to apologize to everyone that I'm from Southern Indiana so as you can tell I have a bit of a southern accent so if you have trouble understanding me please feel free to like craig mentioned to type in a question and we'll get to those at the end of the presentation again my name is John Waters and I've been Hewitt been in the QA capacity since 1997 I was general and general manufacturing from 1997 to 2005 and in 2005 is when I began my career into medical devices now a lot of that experience was spent with the company that I had they weren't educated to what the FDA requires so along with that company me and my them and myself we learned a lot and we learned a fast and I would just like to say that although experience that I had that I do have as far as resolving warning letters FDA inspections I'm happy to say that none of that has happened here at quit mix it was all with a previous company so let's go ahead and get in the presentation I hope that you all don't have to ever worry about how to address an FDA warning letter but if you do hopefully this will come in handy to be of some assistance to you so again my name is John Waters I'm the Quality Assurance Manager here at wit mix I've been in FDA compliance as 2005 I do have five domestic and one overseas FDA inspections and those are quite memorable I won't go into the details here if anyone would like to know the experiences and what to expect you can email me or feel free to call either one I do have numerous ISO medical audits that I have either been the lead participant in or I have participated in just in general and my experience comes from class 1 to class 2 medical devices class threes are something that I have not had the experience yet to participate in and class threes require I won't say a skill level above mine but it's experience that I have yet had to have so what are the objectives of this webinar well trying to think of this from someone like from the dental field some people don't have that exposure to FDA so what I would hope to answer is one just how does one get a warning letter you know if do they all come from the FDA do they come from OSHA or do they come from some other governmental agency and you know just what how does one go about receiving one second one is learn what a warning letter is there are some statements in there that if you are not accustomed of FDA if you are not familiar with their terminology and lingo it can be quite frightening but there is no need for it to be if you're educated about a warning letter and what it is next we want to learn – how to remediate the warning letter there are there is no I want to say there's no form you can fill out there's no pick box that you can do to say well I've done a B and C so the warning letter remediation is fine you need to educate yourself on warning letters on what other people have done to address them and how to go about it and the last is waiting for the conclusion I don't know but again for those who don't have the experience when if you receive a warning letter and you send us your response into the government they don't just automatically email you within a couple days and say hey hey we appreciate the response everything's fine there is quite a lengthy waiting period and a lot of red tape that has to come through the agency before that conclusion can happen so just how does one get a letter well the FDA visits your facility or sometimes a website and they find objectionable methods practices violation of the Q SR I would just like to say that there are many inspections that occur and just because you have an inspection doesn't mean that you're going to get a warning letter but that is an Avenue how a warning letter can come about there are official complaints either an employee or some other agency could say file an official complaint with your organization to the FDA and if that happens the FDA is supposed to conduct an investigation which is called a for-cause one thing you have to know about FDA is FDA plays a different game than that oh sure they play different than other governmental agencies and not to detract from those others but the FDA has the power to shut your company down and no one wants to talk about that and hopefully no one gets to that point and you do have to have some very serious issues going on before they would even approach that but they do have that ability if they needed to pull that out of their tool belt and another way to get a warning letter that has become new within the last two or three years as a websites the FDA has a has an arm that actively looks at not just device company websites but you know smoking seafood all the agencies that FDA has control over they have a specific branch that looks at those websites and if they find objectionable on the website it could be a false misleading statement or sometimes what they call puffery then they can issue a warning letter based specifically off they find on your website but basically if you want to know how one gets a letter it's because there are violations of the quality of system regulation all those avenues that I mentioned and one that I meant to mention as well is if there are several complaints that the FDA FDA has received from a medical device reporting standpoint an MBR is for any time there's a death or serious injury associated with a company's device that information is supposed to be submitted to the FDA and when that happens as it does quite often the agency will take a look at those and if they see a trend if they see something that are that's arising where it looks like that there are more people or more situations in danger they will give you a warning later and sometimes conduct an inspection based off of that review as well so some people don't know what is a warning letter well a warning letter usually begins with opening remarks and it says something about what you have done and the thing that catches most people attention it says your devices are adulterated that's a scary that's something scary to see in writing when when if your if you are not knowledgeable about what this means it looks like that your devices may be exempt from being sold at this moment which isn't what the letter says it all but again this is just some of the remarks that come out of the one letter the warning letter also it lists line item by line item the deficiencies at the agency encountered at your facility there may be some deficiencies that are noted throughout the warning letter where it says you know in this area we found violation a there is a violation in area B or area C and so on and so forth and the agency will list each and every one of those deficiencies the deficiencies that they find they will list it that you had to give a response to so now lastly let's look at some warning letters here's a warning letter it was issued on August 24th 2018 and it's issued December biomed now I just know that this information that you're seeing it's not special it's not controlled anyone can see it if one knows where to look for it it's a again it's addressed to Zimmer biomat and it says that the United States Food and Drug Administration conduct an inspection at Warsaw Indiana and during the inspection FDA determined that your firm is a medical device manufacturer of orthopedic implants so there it says that the FDA acknowledges what they were inspecting that you were a manufacturer of and it says these products are devices and again FDA doesn't give a warning letter for anything but a medical device and it's used in the conditions of the cure mitigation treatment or prevention of disease or to affect the structure of any function of the body and the underlined is where people get a little excited or a little for it says this inspection revealed that your devices are adulterated within the meaning of section 5 of 1 H in that the methods used in or the facilities or controls used for their manufacture packing storage or installation are not in conformity with the current good manufacturing practice requirements of the quality system regulation or the Q SRO for short here's another example of warning letter issued in July 25th 2018 and as you can see it's very similar this particular manufacturer was anagen and it says during the inspection an FDA investigator determined that your firm is a manufacturer of the class 2 and I've blotted out why it was there the type of cups again if you look below it says this inspection revealed that these devices are adulterated so just to let you know that anytime a warning letter is issued it always gives your pleasantries what the FDA was in you were having an investigation for what you're manufacturing and then the devices are adulterated now the last warning letter example is from a dental manufacturer and just because you know I'm not trying to make this manufacture look bad or anything so what I did was I blacked out all information that referred to exactly who the manufacturer was but this was issued a while back in March 27th 2014 and it's through the chief operating officer you can't tell that they're in there in California and again says they were the United States Food and Drug Administration determined that your firm manufacturers dental implants and dental implant abutment systems now while I realize that that's above and beyond what a lot of dental labs are engaged in whether you are a manufacturer of a class 1 or class 2 medical device you are subject to the deregulations now what i'm going to take a look at for this particular warning letter I'm not going to go through the whole thing but I want to look at the first item that they listed for this company okay it says the finding number one failure to establish procedures for design changes as required by 21 CFR 8 2030 now in having the experience that I do if I were to receive this the first thing I would do is go to the CFR regulations from FDA and as look what happen I happen to have a little handy dandy book right here in front of me and Section eight twenty dot thirty I says each manufacturer shall establish and maintain procedures for the identification documentation validation or where appropriate verification review and approval of design changes before their implementation and when it says that the failure to establish procedures in this warning letter it's quite possible that the company had a procedure but if they did they weren't following it and also if they did it wasn't sufficient to meet the FDA's expectations if you go on through the letter you can see that they were that they had screws being used with a button blanks and the inspection found that your firm substituted your own brand titanium screws to be used with the above referenced abutment blanks and implants and did not validate these design changes prior to marketing the abutment system with your screen and if you go on to the the last part it says your response is inadequate and that your firm promised Corrections to validate all product platforms and systems referenced in the FDA 43 which have not yet been completed now there's something I wanted to point out about this the response is inadequate if you do receive a warning letter from the FDA and they say that we'd like to have a response you send that response in just because you send the response it doesn't mean that you addressed it adequately it doesn't mean that that just because you send in response in you you get some favorable points for addressing those the FDA exploit expects compliance and if they say that your response is inadequate that means you have to do it again usually when that happens you either need to get some expert advice in or talk to a consultant or talk to talk to someone who has been in been in the game if you will of addressing warning letters so now let's get into the to the meat of this okay so how how to remediate the letter what should a company do what steps should we take what kind of committee should we form should we get together a task force well unfortunately this is the lot of response that some companies have it's not a wise one I have had in my experience I have had one or two people to call me for advice and they say hey we got this letter and we were supposed to answer it like a month ago but we never did and we've not heard anything from well we will we'll talk about that so first a lot of people have this idea if I ignore it if I ignore the warning letter that will go away well like I say that is not a good option most letters say it you have to respond to them to the warning letter within 15 days of receipt and if you wait past 15 days okay so you're not going to get a knock on the door you're not going to get an email you're not going to get a visit from the agency none of those things will happen on day 16 but just let me say before I say that before confidence that if you are a manufacturer of a class three device if you had had some violations to where people were injured or perhaps people lost their life heaven forbid that does happen if you wait too long then yes they will come to see why you have not addressed them or what is going on that they have not received a response and lastly if you choose to wait if you choose to wait pastor 15 days then prepare for the consequences the FDA have it within their power to come back on day 16 again likely won't happen but when they do come back they will expect an answer of why you didn't do it the first time and usually on a second visit they are not near as tolerant they don't they're not very amicable to work with and that is something that you will have to unfortunately experience on your own and endure the pain that all the pain we can say that FDA can bear so here's something that we need to do you need to prepare for an education and when I say prepare for an education that doesn't mean that you need to go to university although there are some classes that would could greatly benefit you but you're going to have to become immersed in the world of FDA because FDA's rules and regulations what they they live in and breathe the qsr are of the quality system regulation and that's all the understanding if they send someone to your facility for an inspection that person may specialize in they may be a mechanical engineer or they could be a chemical engineer by trade but they have come to work for the FDA the thing about FDA is that any investigator can inspect any facility because they all use the Q SR so the best thing that one can do is get a copy of 21 CFR part 820 there are numerous places on the web where you can either send in and you can get get some of them for free you can get them to come in a convinced version you can get them right off the FDA's website because they are there in their entirety and are again there's there's numerous other places for one can obtain that information when we're talking about this warning letter first of all don't guess what the letter means if you understand that some dental labs are very small facilities with not very many persons that are that are can do business other than what you're there you know day in and day out to do we just make money to address the warning letter it really does take time and effort but again don't guess what that letter means as I pointed out at the very beginning when we were looking up 21 CFR 820 30 if that were in your warning letter you would need to look into this regulation and see what that regulation means some of the regulations are I won't say vague but to a person that is not immersed in your regulations every day it may become it could be confusing it could be unclear what the agency is asking for but again don't guess what the letter means once you get the letter again immerse yourself in the FDA learn and understand what the letter says attend webinars you know like this one look at online training there are numerous courses that people can attend they aren't always in your location or the time that's convenient to you but again if you're addressing a warning letter you need to understand all that you can and you know you need to know what the letter says specifically because they will say generally hopefully some good things as well as some unfavorable things next is learners learn and understand what the letter doesn't say the letter does not say that you have been very that you can't ship your product anymore it doesn't say that we're going to come close your doors the letter does not say those things okay now it is very possible to receive a letter that does say those things fortunately that doesn't happen to you but if you do you should probably get a consultant or someone to help you with that aspect of the letter but again learn understand what the letter doesn't say and you have 15 days now to some people that may not seem a lot of time to some people it may seem like an eternity but you have those 15 days so you don't have to rush and you don't have to spend you know you don't have to stay up for 24 hours a day for the next couple days compiling things that you are going to send to the FDA it is not if you don't know what the letter says do not flood them with information sometimes that's a that's necessary and it requires it but don't just start sending a bunch of information and a bunch of documentation if you don't know what the letter says and what you're sending them and as far as this goes use all the days so again back to the point that you don't have to address all these things in a couple days if you need to bring someone someone in to help you then bring those people in it is possible that if you can if you have someone coming in to help you you can actually put that in your response to the warning liner that says we have someone coming in a consultant or someone coming in that is going to help us address this and we will have a letter to you with no more than 17 days 18 days that is not advisable while some people have done it it is not advisable when the FDA says 15 days you really should have it to them in 15 days okay what does the letter say again educate yourself on the 26 21 CFR part 820 regulations the warning letter will cite the specific violations just like our the example I showed you where that dentals for that dental company received the information that it did from the FDA it cited several violations that the that the letter had out there for the for the owner of the warning letter if you cannot afford the time of resources hire consultant the FDA really accepts no excuses if you if if they were to issue you a warning letter and if you were to get with them at some point in time you know determined yet to be in the future and they come back to you and say why didn't you do this why didn't you give us a response to these findings and even if you say well excuse me mr. mrs. FDA you can see that we are four people here and I don't have the time or the resources to address this letter after all all we're manufacturing is so something to you that doesn't seem very important FDA will not allow that type of a response all FDA ones well maybe that's the wrong way to say it all about what they expect us compliance I've had that said to me before when I was sitting across the table from them quite a few years ago they said we want to see compliance and what you have to do on your end from the company's perspective to keep you in compliance that's what wouldn't that is what one needs to do and lastly I can provide references to a consultant if you like I'm not in you know I I don't get a kickback if I recommend someone I have a couple that I talk with I bounce things off them sometimes sometimes they will bounce things off me but if you find yourself in the predicament where you need to have a consultant address a warning letter I would be more than happy to and cut in in confidentiality so supply you with that information and that's what the letter doesn't say okay now we have to go on some assumptions or some assuming that this is your first warning letter you may have received and you do not manufacture class-3 devices again for those you may not know a class three device is usually is the highest risk of devices and it's usually life-sustaining or again has a very high risk factor to the end user is a class three device the leather doesn't say you are the worst manufacturing company in the United States of America and you should be ashamed of yourself that is not what the letter says again understand that this when the letter says that your products are I'm sorry I just drew a blank that that they are adulterated when the letter says your devices are adulterated that's what every warning letter says and I don't know if I haven't mentioned it yet to this point but just so you know a warning letter in mice does it say excuse me that that's my next bullet point it doesn't say you can no longer sell your products okay you can continue to sell what you're selling as long as you operate within the auspices and the guidelines of the q SR and that if you have violations that the FDA determines you aren't as long as you promise to get them within compliance and you do then you can continue to sell your products but the letter does not say it's a secret and no one else will see it that's what I wanted to say in just a moment ago don't think that this will be a a just a private conversation it's a private correspondence between you and FDA once the FDA issues a warning letter it goes to the agency's website and it is posted if anyone if you would if you'd like to know where that information can be found I would be happy to to let you know but that isn't necessarily within the course of this discussion but just being just be aware that it is not something just between you the agency anyone any company any manufacturer any individual with a computer can access it if they know where to look well not only know what a warning letter is how a person gets the warning letter we know what a warning letter isn't let's talk about remediation how do we correct this morning letter well first of all understand that if you've received the letter the the the the agency will expect you to have a corrective and preventive action procedure or as the as the FDA lingo likes to call it a Kappa now you can call it CA p1 you call it Kappa – oo 1 what you called it is is your business but it is your responsibility to have a procedure for corrective and preventive actions and if you don't have a cap of procedure the agency will will issue you issue you a violation because you don't have one it's best to open the corrective action for every violation noted on the letter there had there are a few instances where you can group some of them together but in issuing a corrective action for each and every one it lets the agency know that hey I'm taking this serious it means something to me and my company that we want to be in compliance with the queue SR so that's why it's best to open a corrective action for every violation on the letter and ensure you address it in its entirety in that a warning letter we looked at before from that dental company I did not dissect that letter to see if everything it mentioned could be addressed in one corrective action but what you don't want to do is just for every for every infraction you don't want to fill them into the pot and tell FDA what we threw them into our cap of pot and we're going to have one big CAPA we're going to have one big corrective action to address all these things the FDA will not accept that they need to know exactly what you are correcting when you say they're going to correct something so they can ensure that you are in compliance with the regulation and lastly with the corrective action there is always a root cause something at the very core that caused this what whatever the violation is something that caused that to happen so you need to be able to determine that and communicate that effectively to the FDA so that they they know you have an effective Kappa program let's talk again it's more about remediation ensure that you address those responsible for correcting the violation notice I did not say ensure you address those responsible for the problem the FDA from a regulatory standpoint they don't care what the source of the problem is they only care that they have identified the problem and it's up to you the company to put a fix in place to correct it rather than saying in a corrective action response some one will take care of ABC it's best to say and you don't it's best to also not use personal names people coming up sometimes in the regulatory world the one responsible for the regulatory program that person is no longer on the roster when a warning letter occurs and while that's it's not funny to anyone's employment it does happen it's but make sure you left the FDA know that you have assigned the responsibility for this to an entity at your facility that will ensure that's being taken care of it's your specific dates are set and they are realistic if you have a corrective action that's going to take you two months to correct the FDA is okay with two months but make sure you say two months don't say I want to get it corrected in ten days because there is always that option that FDA may come back in two months when you say you were going to have it fixed for ten days and if your timetable is longer than what you told them be prepared to have an extensive sit-down with them of why that occurred know that most violations will need to be corrected with the new or updated procedure because if you understand the quality system regulation that is what FDA inspects and audits to is the Q s R so if they point out something to you that isn't correct it will need to have a revised procedure a new procedure something that to them shows that you understood what the problem was you understood what the violation was and you have something new or updated to take care of that situation and here's one of the most important things send copies of any procedure you mentioned so if you have a corrective action and you say we have corrected this situation with our new Q P 101 for a sterilizing product the FDA will acknowledge that and I have seen many warning letter responses where it says you have indicated that you have a new procedure in place however you did not send the copy of that procedure so an additional follow-up inspection will be required to ensure that you are still following the regulation please understand that doesn't mean if you send them copies of any procedure that they won't come in but any in but any meaningful information that you can send to them that shows that you are complying with your regulation that will be better on your behalf for any future inspections remediation number three when I talked a moment ago about a root cause be cautious with root cause of insufficient training I have used this as a root cause when issuing a corrective action and many people use this for a root cause for a corrective action but be cautious with it because it is common and the FDA is it's routine for them to see this as a common root cause keep in mind when FDA wants to know they want to know that you know what caused the problem before you can fix it because if you attend to put a corrective action in place without addressing the root cause they're gonna say that it can occur again because you have not done it many people think that their employees weren't properly trained they weren't they weren't properly informed they didn't have maybe there was a class we should have sent them to so that's why they say or put down as the root cause is insufficient training again just be cautious because FDA will out one or sometimes two is insufficient training to be documented as the root cause but if you become a habit of doing that or you list it multiple times then they will say that training is one of the problems with your quality system because every time there is a corrective action you say that there's insufficient training someone should have had a class they didn't that they didn't go to something of that effect and so that will be either when they leave the building or possibly in a future response to you the FDA will say that another violation you are dealing with is insufficient training or an insufficient training program remediation number four and just like the procedures if there's any documentation you generate as a correcting as a correction to the finding send copies okay if you do some retraining you need to send that training form with the individual signatures with their names law – he'll printed on one side and in cursive on the other and the date that the training occurred and what the training was for if you say that there is that there has been some new training again it's just like the procedure they don't know that unless you send the documentation the argument always exists with some of those who like to be the devil's advocate that well just because I sent the information doesn't mean that I really did it and they're correct and if one wanted to have that viewpoint that would be correct the danger is when FDA comes back and they will come back at some point time in the future that they will see whether you really did it or whether you did it the FDA is good at what they do and in addition to the to the training records and the procedures if you have any type of form to record information that you think is very meaningful and helpful to address the corrective action then send the new or amended forms again any information you can send to them the better meaningful information if you have a new procedure protocols validations or letters of rationales sometimes there are parts of the q sr that you are exempt from that you do not have to comply with it and when the FDA came in they may have taken again they don't they don't stay you know all inspector program they're usually there from three to seven days unless you have a big facility or the violations they encounter are pretty severe then they can stay longer but if if if a particular portion of the regulation doesn't apply to you you can have a rationale written that says this doesn't apply to us in fly but again you can't just say I know it doesn't and expect the FDA to be okay with that you have to send them the information and the documentation that proves that again FDA is always looking for proof and the FDA doesn't they don't want to see it's not that important if there is a portion of the regulation that doesn't apply to you don't say it's not that important put information in there that explains perhaps what a requirement is and why your particular operation or your device doesn't need to comply with it again FDA does not like to see that which they have seen in the past some and now you may ask what that's a lot we just talked about how can I do all that in 15 days well one doesn't have to have all the Corrections done in 15 days this is something that that is important as a manufacturer in responding to a warning letter that you need to know for each action when we've talked earlier about you have a timeline how long how long it will take to complete that's okay if you say it's going to take I can get it done in five days then you should get it done in five days if you say it's going to take 12 months say it's going to take 12 months again that depends on the seriousness of the violation that depends on the risk to the end-user and to the patient but give a timeline that is reasonable and FDA will expect major Corrections to take time in the facility that I was at years ago we had what was called a forum fill and sill machine that was it was an aging piece of equipment and so in when the FDA had inspected that some of our the the packaging was at what they thought it should be we addressed that by saying we're gonna buy a new machine and it took 18 months from the time of that visit till we could secure purchase orders till we could validate the machine we could execute the proper protocols and we had the machine installed and my company so again they are okay with a time line you just have to make sure and make sure that it's realistic you know and I just like to say we're getting close to wrapping up there is no FDA one-size-fits-all and just to let you know that these guidances and those are they are from my experience with the FDA I have attended numerous FDA conferences and I've got a chance to interact with some other colleagues there and but with the conversations that we have had my experiences are not unique which means that the FDA pretty much inspects and audits all the same because all investigators are trained the same but all audit differently and ask different questions with different specialities you may get an investigator today that is very amicable very very pleasant to work with in the next year or two different time you may get their coworker and they make your they may make your life very miserable for the time that they are there so just be understand that all investigators are trained the same but all audit differently okay well you've you've answered the letter you put all your corrective actions together you've got all your responses the things that you want to send and you and you've sent them to the FDA and now you're waiting for response but what you have to understand is FDA operates on their timetable okay if your violations pose no serious threat to safety they are in no rush sometimes they have airborne food illnesses anytime that they that an agency anytime a department that the FDA interacts with if there is a national emergency or health scare they will put your issues off if there if you have no violations and you pose no serious threat here is here's a big hint if you haven't heard from the agency in a few weeks don't call them don't email them don't say hey you know we got this warning letter and we sent a response in and we're waiting to hear from you that's not wise anytime you interact with the agency don't communicate with them unless they ask you to or unless it's a mandatory thing that you need to do and finally when you do receive the final results and sure you are aware of what the closeout letter says ensure that the that's a letter like the example that I just showed previously if it says that your response is inadequate that means you have to reply in that doesn't mean that you just well you said it's inadequate and in your mind you're thinking well we'll just have it fixed when they come to for the next time that isn't what FDA means they mean you need to send something else that is satisfactory then again to show that you are compliance with their regulation and that's the end of my presentation I hope that that has been helpful I hope it doesn't leave you too scared if there's anything as long as it pays it's a five-minute conversation I will be more than happy to have a conversation or email dialog with you to talk about some other issues with it with FDA but with that I hope this helps those that listen today thank you and have a good day thank you I appreciate that information and the wealth of knowledge that comes behind it we do have a couple of questions for you I thought it would be appropriate to ask and the first one is about the seminar is this only for those with a class 2 medical FDA 510k permit well that that is a very good question I would have to look at the devices that a person is manufacturing some class one devices are exempt from the regulation some are not not most are exempt but some are not and whatever device that you were manufacturing I would have to look at the the device class but the product regulation number and to see whether it is exempt or not or you know I can if you tell me whoever this person is email me I can see me the information where you can find it but it would be easy for me to just to look it up so I'm sorry that I can't answer that question other than to say that most class one devices are exempt however some are not okay excellent now the second question is I thought the FDA would only visit my lab if I was a class two or three type laboratory that is incorrect via to keep in mind the FDA kenning it can and visit anyone anytime any medical device manufacturer that they want now you are correct in part that if you are manufacturing devices that are exempt from the regulation most of the time you will never see them but even if you are manufacturing a device that is exempt and you are manufacturing a device that for heaven forbid somehow someway has the ability to cause someone harm or you know a serious injury or death and that happens at least once and if happens more often you can guarantee a visit from the FDA again FDA sometimes they like to leverage their power and they show others that that they can wield their power whenever they want wherever they want but again it only applies to medical device manufacturing but if you unfortunately fall under one of those categories even if you are just a class one and you could expect to visit okay great well those are our two questions that we have today remind everybody that if you do have any other question that you can certainly email us at the technical support department at the witness' corporation or give us phone call either way we will find an answer for you and just a reminder that this webinar was recorded so you can watch it again if you so desire expect for those of you who signed up for the expect that there will be a letter or an email for you it's an email for you regarding your C e credits within a short period I think that's it and John appreciate you and everybody else Thanks come join us again

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