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No one looks forward to having the FDA come to inspect their facility, but you always need to be ready for it, as you might be subject to an inspection as frequently as every two years.We want to put your mind at ease by giving you information on how to best prepare for FDA inspections, which can take a minimum of five to seven days.
On today’s episode, we’re introducing the newest addition to the Greenlight Guru team, Jesseca Lyons. Jesseca is guest of host Jon Speer and the two are discussing FDA inspections.
Jesseca is a 2007 graduate of Rose-Hulman Institute of Technology and has worked in the medical device product development for nearly 10 years. She worked in custom integration at Beckman Coulter, then worked on getting medical devices transferred to manufacturing at CRI, a medical device contract manufacture.
Jesseca talks about her role at Greenlight Guru, which is making sure the customers are successful, in whatever form that takes.
Why FDA inspections are high-stress.
How to prepare for an FDA inspection.
What to expect during your inspection?
Why the FDA nearly always finds potentially questionable items.
How to react if you receive a 483 warning letter.
What to do in order to resolve issues found during your inspection.
What FDA data is available to the public.
“It doesn’t matter your size, shape or how long you’ve been around. You’ll go through an FDA inspection.” – Jon Speer
“The FDA seems to find the one piece of information you wish they wouldn’t.” – Jesseca Lyons
Now if you liked today’s episode, then I know you’re going to find the free webinar we have coming up valuable. It’s titled, “How to Avoid and Respond to FDA 483’s and Warning Letters.”
Announcer: Welcome to the Global Medical Device Podcast where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Jon Speer: How long has it been since your last FDA inspection? Are you ready? Do you know what to do? This is Jon Speer, founder and VP of quality and regulatory at greenlight.guru. And on this episode of the Global Medical Device Podcast, you're gonna meet the newest member of the Greenlight team, Jesseca Lyons. And Jesseca and I are gonna talk a little bit about FDA inspections, and 483 observations, and warning letters, and it's all about preparing you for the upcoming webinar that we have at greenlight.guru about how to avoid and respond to FDA 483s and warning letters. This is being hosted on May the 26th at 1:00 PM, Eastern time. So be sure to go to greenlight.guru and sign up for the webinar. And be sure to listen to this exciting episode of the Global Medical Device Podcast.
Jon Speer: Hello. This is Jon Speer and welcome to another exciting episode of the Global Medical Device Podcast. Today, I have an exciting guest, a special guest. She is the latest and greatest addition to the Greenlight team. Ladies and gentlemen, welcome to the podcast, and to Greenlight, and to your world in the medical device industry, welcome, Jesseca Lyons.
Jesseca Lyons: Hi!
Jon Speer: Jesseca. Yeah, say hello.
Jesseca Lyons: It's fun to be on here. I've been with Greenlight now for about a month. So, it's been a fast paced last few weeks.
Jon Speer: Yeah. So tell everybody a little bit about your role and a little bit about your background that led you to the greenlight.guru team.
Jesseca Lyons: So, starting with my background. I'm a Rose-Hulman graduate. Graduated as a mechanical engineer in 2007 and got started after that at Beckman Coulter for four years in custom integrations, learning all about the product development life cycle that way. And then the last two years, I have spent working at CRI, helping get things, medical devices transferred into manufacturing. So I've seen the beginning and the end.
Jon Speer: And CRI, for those who may not know what CRI is, it's not some new crime scene show on CBS. It's actually catheter research.
Jesseca Lyons: Right. So they're a contract manufacturer. And so that's where I got to see the beginning life cycle stuff, helping customers bring product to market, and then once they've gotten their clearances, helping them actually get it manufactured.
Jon Speer: Yeah. And so you've been at this now for, I think, what, 10 years?
Jesseca Lyons: Almost. Yeah.
Jon Speer: Almost 10 years. Coming up on an anniversary.
Jesseca Lyons: Yep.
Jon Speer: That's a big deal. You're gonna go back to college and catch up with your old classmates. 10-year deal, that's a big deal, right?
Jesseca Lyons: Yeah. No, we're already planning on going back for homecoming, so looking forward to that.
Jon Speer: Cool. Well, Jesseca, I had the privilege of knowing and working with Jesseca before greenlight.guru many, many years ago. And that's where I first understood and got to kinda peek inside your brain, so to speak.
Jesseca Lyons: That's a scary place to be.
Jon Speer: Well, I don't know, you told me it was a great place to be.
Jesseca Lyons: Well...
Jon Speer: You're process-oriented, you're systems-oriented, and things of that nature.
Jesseca Lyons: Some people are scared by the process.
Jon Speer: I don't wanna see how things... It's like, watching sausage, you don't wanna watch it, but as long as the sausage tastes good and it's kind of what counts? Sure, maybe?
Jesseca Lyons: We'll go with it.
Jon Speer: Alright. Alright. So tell us a little bit about what you're doing here at greenlight.guru.
Jesseca Lyons: So what I'm doing here at Greenlight is making customers successful. Whatever that takes. I'm helping train, showing you how to use the software, making sure you understand what buttons to click, when. With new features coming out, making sure you understand how to use those new features. And then the greatest part is that I'm helping you solve your problems. So if you don't understand how to do design inputs or what is a user need, I get to go through and explain that and help educate and train, and that is... That is what I do. That's the most exciting thing.
Jon Speer: Yeah. The most exciting for me is, I think, sometimes there's a bit of a misnomer if somebody thinks about greenlight.guru the same that they... That may pop into somebody's head is that we are a software company. Yes, it is true, we have software. But you also have people like Jesseca and myself, as well as our team of gurus, who are med device experts. We've been doing this for quite some time. Whether it's product development or quality or regulatory, and we actually provide services, support services, to customers, if and when they need that, whether, as Jesseca said, it's helping them determine what a design input is versus a user need. And we just had a call with a customer, a little bit ago talking about the difference between hazardous situation and harm from a risk management perspective. So we do focus a great deal on content, and one of these things that you've been a part of, I guess, as more of a participant, and we're gonna get you more involved as one of the behind-the-scenes resources or things like podcasts, like today, and content pieces, writing blogs, I know you're working on that, and then also webinars and things like that. Speaking of webinars...
Jesseca Lyons: We do have one upcoming.
Jon Speer: We do, and it's all about the wonderful FDA inspection process.
Jesseca Lyons: Oh, you mean the scary FDA inspection process?
Jon Speer: Yeah.
Jesseca Lyons: I don't know. It's intimidating.
Jon Speer: It is, yeah. It is intimidating. I've been through FDA inspections... I guess I should actually go back in time and come up with a count, but let's just say a lot.
Jesseca Lyons: Oh, see, I haven't been through any FDA inspections. I've been through ISO. And that was scary and intimidating as it is. And that was the easy audit.
Jon Speer: Yeah. I mean, there is a difference, for sure. I mean, similar in scope, but way different as far the feeling that you have going through ISO audit versus an FDA inspection.
Jesseca Lyons: Yeah, I imagine.
Jon Speer: I mean, because you feel like during an FDA inspection... I don't know. I mean, let's be real, an FDA inspector is a law enforcement official. They have badges.
Jesseca Lyons: Well, and you hear the horror stories of they're very intimidating.
Jon Speer: You do.
Jesseca Lyons: And they stare at you and you feel that compelling silence that you have to fill.
Jon Speer: You do, yeah, that's a true story. I just was in an FDA inspection a couple weeks ago. There was a lot of moments where there was awkward silence. And it's actually a tactic that can be employed by some FDA inspectors. And if you're not comfortable with that awkward silence, you will start blabbing and you start talking.
Jesseca Lyons: It works really well.
Jon Speer: It does. I mean, even in ISO situations, it happens. But in an FDA perspective, I mean, it does feel sort of like an "us versus them" sort of thing. Like, "They're out to get us," sort of thing. And I certainly understand that, but it is a high stress thing, and I think it's one of these things that med device companies, they don't believe it's gonna happen to them. They don't believe that there will be an FDA inspection.
Jesseca Lyons: Yeah, which is kind of odd that people don't believe it'll happen, considering that the FDA tells you what will come at some point. Within two years, "We'll come take a look at what you've done."
Jon Speer: Right. Right. And it's true. I mean, if you're gonna have a Class 2 or Class 3 device, the FDA is mandated to inspect you every two years. Realistically speaking, they don't always get to every company every two years, but they will come inspect you. I promise they will. And it's gonna happen. I mean, like I said, the one most recent that I dealt with is, it's a little three-person company. They've been making a device for... Same device, single device for almost 40 years. And it's a pretty low risk product, there haven't been any issues with it. But FDA shows up every couple years to go through the FDA inspection. And it doesn't matter your size or shape or how long you've been around, you will go through an FDA inspection.
Jesseca Lyons: So, how do we prepare?
Jon Speer: Well, okay, so that's a great question and I can go super deep on this, but first and foremost, you need to have a quality system and you probably need to make sure that that quality system is up to speed. And depending on where you are in the continuum, I'm gonna make the assumption that you have a device that has been cleared or you're preparing for that device clearance. You should definitely have a quality management system that aligns with the FDA's 21 CFR Part 820 regulations. So that's a first piece. So, next, I mean, there's a lot of things you can do. There are things you can go and you can bring in a person like you or me, and have somebody do a gap analysis, go through your procedures, go through your documents, go through your records. You can certainly do that as well, which that can be a little expensive and a little time consuming. You do have an... You should have an internal auditing program.
Jon Speer: And so that internal auditing program, if it's robust, it should be really more... Hopefully more stringent and more difficult than an FDA inspection or ISO audit. And so even if it's not, it should help you prepare and identify areas of weakness, things that you need to improve upon. I will also encourage you to go check out the FDA publishes. This is the beautiful thing about the FDA, Jesseca, they tell you what the regulations are, so it's free. You don't have to pay for it. 21 CFR Part 820 and they tell you everything that you need to put into your quality system. And then they publish the guide to quality system inspection techniques.
Jon Speer: The guidance document. And sometimes people refer to that as QSIT, Q-S-I-T, but they tell you what they're going to look at during their inspection of your facility. So you have their audit plan, so to speak, or their inspection plan, even ahead of time. So I would encourage you to go read that too.
Jesseca Lyons: So why is it so scary?
Jon Speer: Well, it's scary because they're gonna be looking at everything. They're gonna be looking at records. And so, let me put you in the context of that FDA inspection. Let's imagine that you got the phone call or the knock on the door and the FDA says, "Hey, Jesseca, Jesseca. This is Jon. I'm from the FDA." Knee jerk reaction. How do you respond to that?
Jesseca Lyons: Oh, dear. No.
Jon Speer: "Well, Jesseca, it's time for your FDA inspection." It's not like you're on a game show or anything, but I'm gonna coordinate with you. "So Jesseca, I'm gonna come to your facility next week. I'm gonna be there on Tuesday and we're gonna start your FDA inspection." And then what do you do? How do you react to that?
Jesseca Lyons: You start pulling every document you've got. And freaking out.
Jon Speer: You start freaking out, for sure. And that's a pretty knee jerk reaction. It's a pretty natural response. But I do want you as... Jesseca, I'm a human, you're a human, we are people too. So, but you should definitely be prepared. But here's the trick, if that FDA phone call or the knock on the door freaks you out, go through that freakout right now as you're listening to this podcast. Realize that you need to always be ready for an FDA inspection 'cause you don't know when they're gonna show up.
Jesseca Lyons: No, you really don't.
Jon Speer: I mean, best case scenario, they call you ahead of time and they tell you, "We're gonna come into your facility here in a couple days or a few weeks," but they don't have to call you, they can just show up. So you should always be ready for an FDA inspection. Alright, so that's a little bit about kind of the prep, but let's go to... Let's talk a little bit about what happens when FDA inspector shows up to your facility.
Jesseca Lyons: Yeah. They always seem to find the one piece that you wish they wouldn't.
Jon Speer: Yeah, it happens. So, it's important. Let me try and take you through what that... The start of your FDA inspection is gonna be like. So the FDA inspector is gonna show up to your facility, usually at the time that they said they're gonna be there. They're going to pull out their badge, their credential, they're gonna show everybody their credential. Yes, FDA inspectors, they have badges and IDs and all that sort of thing. And then they're going to... They're gonna go through a short interview process. They're gonna issue a Form, 482 notice of inspection. They will give that to you, which is basically a document that just says, "Hey, med device company, I'm from the FDA, and I'm here to do your inspection." [chuckle]
Jesseca Lyons: It's kinda redundant considering when they show up. But it's really what they're there for.
Jon Speer: I mean, it's a legality thing. Keep in mind, everything that they're doing, they're documenting along the way, and there will be reports and communications throughout a number of different divisions and groups within the agency once your inspection is done. So, they'll ask a whole bunch of questions about your business, and it's always good for you to be prepared, and have sample products available, to be able to kinda describe, at least from a high level, what those products are, and keep in mind that everything you say should be in alignment with the cleared indications for use for your products. It's good to have things like data sheets and operators manuals handy. But I think if you can... The more you can educate and inform that FDA inspector what your product is, how it works, that's gonna be helpful. Alright so, I may be rambling a bit. What other burning questions do you have about going through the FDA process?
Jesseca Lyons: So, why do they always find something that might be questionable?
Jon Speer: Yeah. Well, keep in mind, the FDA's job is really about protecting healthcare consumers. And it's their job to make sure that the products that are in the use for medical purposes are safe and effective. It's the whole regulatory product classification process to get a device cleared and registered to the market is commensurate with the risk that the product poses. And the way the FDA keeps tabs or ensure on an ongoing consistent basis that the products are safe is through a couple of mechanisms. One mechanism is through the reporting program that they have. So if you are a manufacturer and there are serious events, adverse events that are happening with your products, you need to report those events through the medical device reporting program with the FDA. Healthcare facilities can also contribute to that program, but it's voluntary for the healthcare facilities. So that's one area where the FDA's monitoring what's happening with products. And then the other area where they check, it's through the inspection. The FDA inspection, the on-site inspections. And they're gonna dig into things, like probably start in an area either with complaints or with CAPAs and they're just gonna trace basically everything through your entire records and documentation, and basically sample numerous records, numerous CAPAs, numerous complaints and just follow that thread, kind of all the way through your entire process.
Jon Speer: They're gonna go all the way back to the origin, the design of development activities. And so if you can imagine that every step along the way they're pulling CAPAs and complaints and non-conformances and deviations and inspection forms, and DMRs, and DHRs, and DHFs and all the stuff that goes into that, there's a pretty good chance they're gonna find a document, or a record, that the inspector is gonna have some sort of issue or discrepancy with.
Jesseca Lyons: So there is no way that one person knows everything there is to know about the entire product line from start to finish.
Jon Speer: No.
Jesseca Lyons: How many people are involved in these audits?
Jon Speer: Well, I mentioned that my recent story was a three-person company. And that's a bit tricky to manage an FDA inspection in a three-person company. Me being there made it the fourth person. [chuckle] I would say an ideal scenario, let me describe that a bit first. An ideal scenario that you have a two-room system set up. You have the main room, the war room so to speak, where the FDA inspector is there with your management representative. And then you'd have your team of subject matter experts that depending on what the topic is, or what the product is, or what have you, that you've identified who these people are. You may have a subject matter expert for CAPA, you may have a subject matter expert for product X, you may have a subject matter expert for product Y. And so you identify those SMEs in your team. And then as those topics come up in the course of that FDA inspection, you're grabbing each of these subject matter experts.
Jon Speer: And then in the second room, you have a back room. And so the FDA inspector is going to... He or she is going to make a request for a record, or, "Can see this?" or "Can I see that?" And you should have the war room... Somebody in the war room communicating with somebody in the back room. And so as these requests come in, the back room goes and retrieves the document, reviews the document. Basically, gets the gist of what in that document ahead of time. And granted, you're right, nobody can know every single detail of every single product, document, record. And reviewing it just a few minutes before it comes into the war room, I mean, that's not an ideal scenario, either, but obviously the FDA doesn't send you a list and say, "We want you to pick these five CAPAs and these 12 complaints" and so on, to some extent, you can have to roll with it. And this is why it's important to not freak out during the... When you get the phone call that says, "Hey I'm FDA, I'm showing up." This is why it's important for you to be ready for the FDA inspection any time, so that you're kinda always on, you always know, that this process is good and that we've got records here, and so on.
Jesseca Lyons: Sounds like it's also always good to be very thorough in your documentation, so that if somebody else is taking a look at it down the road, they're able to actually follow what you've done.
Jon Speer: Yeah. I think, out of anything that you can think about, realize that... Yeah. Let's be real. You and I are engineers, we've worked with a lot of engineers. You and I may be somewhat of exceptions. I don't mean to generalize too much here, but I know plenty of engineers that I've said, "Alright, yes or no. Do you like documentation?" Most Engineers are gonna say...
Jesseca Lyons: No.
Jon Speer: No. And I would say in general, that's sort of the mentality that not just engineers, but a lot of people in the med device industry, because it feels like sometimes that all these regulations are forcing us to create a lot of documents that are a waste of time.
Jesseca Lyons: Mountains and mountains of paperwork.
Jon Speer: Yeah, a former employer, he used to refer to it as "the paper blizzard," right? So, there's a lot of negative connotation when it comes to documentation and record keeping. But I think it's very important for you to realize that as you're going through your product development process, or as you're documenting risk, or as you're capturing the details of a particular complaint, or whatever the case may be. That effort of documenting that event isn't for you in that moment in time, it's for somebody else in your company at some moment in time in the future, like an FDA inspection. You gotta consider that anything that you document, that you record, and store, manage, maintain, in your company's records could be part of an FDA inspection someday.
Jesseca Lyons: Very good point.
Jon Speer: Conversely, anything you don't document could also be subject of your FDA inspection as well, which there are plenty of things that you should not document, but if it's related to complying with your procedures, and with complying with the FDA 820 regulations, then you should be documenting it.
Jesseca Lyons: Absolutely. If you don't document it, it didn't happen.
Jon Speer: That's what I hear, yeah. So, anything else? Burning questions that you have? And I can't wait for the next time I have an FDA inspection come up at...
Jesseca Lyons: That makes one of us.
Jon Speer: Well, I mean it's... Well, I was going to say 'cause I was gonna have you sit in and join in the process. Probably good to know a little bit else about, "Okay, they're here. How long are they gonna be here?" Probably good to know a little bit about, then what happens after the FDA inspection and what do you do there as well. And you can expect an FDA inspection, it's very plausible that it could take easily five to seven days.
Jesseca Lyons: Wow, that's a lot.
Jon Speer: It is a lot. It doesn't matter if you're big or small. It's probably gonna be a five to seven day process minimum. That's not the average or maximum. That's the minimum. If they find stuff, they'll be there longer, but once the FDA inspection wrapped up, you're gonna get what's known... You may not. You may be one of those lucky companies that has no further action required.
Jesseca Lyons: We'll have a party and cheer.
Jon Speer: If you have no further action required from your FDA inspection, yeah, that's a big deal. It's a little bit more likely to expect that you're gonna get what's known as a 483 observation.
Jesseca Lyons: Uh-oh.
Jon Speer: Well, yeah, it's a big deal. Basically, a 483 observation, the number 483, I mentioned earlier, the Form 482, notice of inspection. Well, once you've had your inspection and there is results of that inspection, any issues that the inspector identifies during that inspection will be documented on an FDA Form 483.
Jesseca Lyons: They assign numbers just like the rest us?
Jon Speer: They assign document numbers, yep, just like everybody else. So, if you have discrepancies or issues or deficiencies with respect to the evidence that the inspector observed, then that's gonna be captured on a Form 483.
Jesseca Lyons: So, how do I refute that? What if I think they're wrong?
Jon Speer: Well, if you think they're wrong, it is a bit of a delicate process as you're going through the inspection. If you're not clear about why the FDA inspector has identified something as an issue, you should ask, "Why is this?" And not in a way that's contentious, but in a way that's trying to get education and information. You do have an opportunity to dispute that in a, I guess, in a friendly sort of way during the inspection. And give yourself an opportunity to provide substantial, objective evidence to support your claim, don't just say, "Well I don't agree." Be sure you can support it with objective evidence or documentation. And if you felt like you've done that and you built your case to... And you still got the 483 observation there is a whole escalation process, I'm not gonna get into it here, but you can certainly dispute that. You can go through... The FDA does have an escalation process where you can say, "I don't agree with this," and so on. But let's imagine you agree, you realize you've got some issues then there's a whole bunch of 483s, that 483 observations that FDA have documented. Now you need to provide a written response to the FDA.
Jesseca Lyons: How quickly do I have to do that?
Jon Speer: You have to do so within 15 days of receiving your 483s.
Jesseca Lyons: Okay. So at least they give you some time?
Jon Speer: They give you a little bit of time. And they don't expect you to solve everything within 15 days. They expect you to communicate the root cause, they expect you to communicate the corrective action plan in some detail. And in my experience, you're gonna identify... You're gonna start to capture CAPAs or corrective actions for each of your observations, you're gonna identify an action plan, you're gonna identify a relative timeline, although that's a little less important, you're gonna identify your root cause, and you're gonna communicate to FDA, "Here's what we're gonna do about it." And you're gonna specify to the FDA, "We expect all of these issues to be addressed within three months or six months," or whatever the case may be. And then you'll set the stage and say, "We're gonna communicate with you every four weeks or every month or every six weeks, but we're gonna continue to follow up with you and communicate to you, FDA, our progress on this, and we're gonna do so until we've completed everything." So there's a little bit of a formality there. There's certainly documentation that you wanna keep a pretty good record of that.
Jon Speer: My recommendation is to go overboard to some extent. Certainly monthly updates in the beginning are good. Giving FDA more and more information about what you're doing about this is important. Make the FDA tell you, "Alright stop, stop sending us so much information" right? Kind of go to that extreme, because you want to clearly communicate to FDA, "This is what we're doing about it, and here's the evidence as we're going through this process that we're fixing this."
Jesseca Lyons: Do they have to approve of our plan when we submit that at the end of the 15 days or within that 15 days?
Jon Speer: Well, they don't necessarily have to approve of your plan per se. If they disagree with something that you're communicating to them, they are likely to bring that to your attention, but don't expect that to be a super fast process. You may be several weeks into this before you would hear back and say, "Yeah, we don't agree," or something to that extent. It's also possible that if the issues are serious enough, then FDA might send it up the food chain, so to speak. And it's possible that you could get a warning letter from the situation, but generally speaking in my experience, that's why you ask the questions during the FDA inspection, understand what the issue is and understand... Start to formulate the ideas about how to address and resolve this before that inspector leaves, now that inspector is not gonna say, "Yes, I agree with your plan," necessarily, but it should give you some good ideas. So any other question that you have that you can think of right now about FDA inspections?
Jesseca Lyons: So since they are MDRs, those are public, you can go out there and search for things. What about all these issues with my... I mean, you see copies of warning letters out there, and when you go to conferences you hear people saying, "Don't do this, don't do that." What information is actually out there for everyone?
Jon Speer: Sure. So the form 483s that are issued to companies, that's not in the public domain. So you can't see if I have received 483 observations from FDA. If I get a warning letter, yeah, that is in the pubic domain. What you can find is, you can find FDA does publish their data on the issues why companies are getting 483 observations. They do that on an annual basis. For example, design control once again in 2015 was the number one reason why companies got 483 observations, and it's like number two reason why companies get warning letters. So you can get data and information there but, again, just to encourage you all, it's not a surprise. Follow the regulations, follow the guidance document, and that's the best source. So you can find a lot of information and certainly you can ask people like you and I, and we read this stuff for entertainment at times. But you and everyone else know, remind everyone that we do have a webinar coming up here at May the 26th at 1:00 PM Eastern Time, and we're gonna dive into this and a lot more. And the topic is, "How to avoid and respond to FDA 483s and warning letters," and we'll get into a lot more depth and detail. So I encourage everyone to go to greenlight.guru and sign up for the webinar.
Jesseca Lyons: Well, I know, I will definitely be there.
Jon Speer: Yes, you will. Alright. Well, enjoyed having you... Introducing you to the rest of the greenlight.guru Global Medical Device Podcast audience, and look forward to having everyone sit in and enjoy the webinar on FDA 483s and warning letters.
Jesseca Lyons: And I look forward to working with everyone at some point in the future.
Jon Speer: All right, talk to everybody soon.
Jesseca Lyons: Bye.
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...