In-Person Ways to Avoid Form 483 Observations and Warning Letters

An FDA inspection can be nerve-wracking. Learn what two experts say you can do in person during an inspection to avoid receiving Form 483 observations or a warning letter.

Marie Thibault

For many medical device companies, it's a scary idea that an FDA inspector could show up at your reception desk tomorrow—or even today. Device executives need to ensure that everyone, from their regulatory affairs team to their receptionist, know how to interact with FDA personnel.

Speaking at the Regulatory Affairs Professionals Society (RAPS) 2015 Regulatory Convergence in Baltimore recently, Pamela Furman Forrest, JD, partner at King & Spalding LLP, and Norman Rabin, director of Solutions Delivery at Maetrics LLC, gave the audience practical pointers on how to interact with FDA staff in person during these inspections. 

Before the Inspection Happens

Because an inspection can happen at any time and FDA does not have to give prior notice, it's key to prepare everyone and have a trained response team with a clear plan in place, Rabin pointed out. "The first person—that includes the reception person in the lobby—is the first face that the FDA sees from your firm. That person has to know what to do when the FDA walks through the door and shows the badge . . . " he said.

Preparation includes designating primary and secondary hosts for the inspection, in case the first person is gone on the day the FDA inspector arrives, and there should also be at least two of what Rabin calls "official scribes," to record what takes place during the inspection. 

Everyone on the response team should know what their duties are and should clearly understand the process that will take place in both the front room (to host the inspector) and the back room (personnel working to fulfill inspector requests), Rabin said. He also recommended that the team review past 483 observations, warning letters, recalls, open corrective and preventive actions (CAPAs), and open complaints, among other items.

During the Inspection

To start the inspection, the FDA inspector should be required to follow the normal guest check-in process for the facility, Rabin said. The reception person should then call the inspection host, who will then call the back room coordinator. That back room coordinator can then inform the rest of the team that an inspection is taking place.

Give the inspector a site presentation, and while this introduction is being made, department managers should tour the facility to ensure everything is in the best possible shape. Rabin said, "You can't fix what can't be fixed, but if you've got pallets in the middle of the aisleway, you've got things that are in disarray, you can certainly correct those things right off the bat," he said.

In the front room, the two scribes follow the inspector's questions and requests, as well as the company's responses, Rabin explained, and then the requests are sent to the backroom, where the request is fulfilled. He believes it is important for the back room personnel to follow these steps when they receive a request:

Rabin also said that it's important to "treat the inspector with the respect due any person." Of course, hostile or contentious behavior is "never a good idea," he said. 

But how to deal with those inspectors who may be known for notoriously zealous inspections? "They're human . . . you don't want to be overtly friendly or over the top," Rabin said in an interview with MD+DI after the RAPS presentation. In some cases, those inspectors with a tough reputation are just extremely knowledgeable and "if you treat them as a human being, you may get a response as a human being!" he said.

At the End of Each Inspection Day

Inspections often take multiple days. and though some large manufacturers may be accustomed to months-long inspections, other companies may see their inspector from time to time over a series of weeks. Forrest explained, "It's not being in there everyday for six months sometimes, but it's the investigator is doing another inspection and is going back and forth . . . it's becoming more and more common, in my experience."  

With this in mind, Rabin said it's important to ask for a daily close-out meeting to get clarification on any matters from the day and even to ask directly if the inspector has any observations to name from the day. "You ask them point blank, 'Do we have any observations today?'," he said. If there are observations, discuss them with the inspector in order to immediately get them in the proper context. "I've been in inspections that have gone on for six months . . . that context can get lost by the time that amount of time passes."

Post-Inspection

What if—despite your best intentions—your company has received a 483 observation or warning letter anyway? Forrest detailed numerous perils to avoid when preparing a written response to FDA, including "excessive self-incrimination," neglecting to closely review all supporting documents before sending the response, missing the response deadline, and lacking clarity in your writing.

There's also the opportunity to meet with FDA in person, Forrest said. "For a serious 483 and a warning letter, I almost always encourage clients to request a meeting. Are you always going to get it? No. FDA is becoming more and more parsimonious, the district offices, with granting meetings, but if you have a serious 483 and you get in to meet with FDA, it can potentially give you an opportunity to avoid a warning letter."

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie. 

[Image courtesy of MASTER ISOLATED IMAGES/FREEDIGITALPHOTOS.NET]