Companies Aren’t Required To Respond To FDA 483s

Companies Aren’t Required To Respond To FDA 483s

May 15th, 2024 // 11:11 pm @

A common question from drug and device manufacturers is how to respond to an FDA 483 or warning letter. Many employers think that the company has to respond to the FDA citation within 15 days, but this isn’t true, according to Gina Brackett, who is the director of compliance at the Office of Medical Device and Radiological Health Operations, or OMDRHO.

She noted at a May 2024 RAPS conference in Washington, DC, that companies aren’t mandated to respond to a mere 483 in 15 calendar days, Rather, the 15-day deadline is for the FDA is planning to send a warning letter. Brackett said if your firm wants their response noted in the warning letter, it’s required to respond within 15 calendar days.

How To Respond To An FDA Warning Letter Effectively

Remember, Brackett said, a warning letter requires a response, but not the 483. The reason there is a 15-day response requirement is that the agency would get a 483 response mere days before the warning letter was issued. However, the director of compliance at OMDRHO said that FDAers will review 483 responses that come in after 15 calendar days.

Next, Brackett told the RAPS audience that drug and device manufacturers should be direct and honest in how they respond to the warning letter. It’s important not to overpromise about changes and under-deliver. FDA understands that major cGMP and device issues are not going to be fixed in a week. The agency also knows that the company may not necessarily have a protocol set up before crafting the warning letter response. Both processes can take at least a few weeks.

Jessica Zeller, VP of Quality, Environmental, Regulatory, and Public Affairs Counsel, Edwards Life Sciences, also cautioned the RAPS audience about overpromising on your warning letter response. She said you need to be as specific as you can and comprehensive. If you say you will have the fixes done in 15 days and the agency asks to see them on day 20, you will lose credibility if you don’t have anything to show them after 30 or 60 days.

She also said that some device and drug companies are still choosing to respond to the warning letter within 15 calendar days. But it’s important to be thorough, and if the issue was noted in a warning letter, putting together a comprehensive response in such a short time is challenging. It’s better to take longer to respond than to rush things, Zeller added. Often, understanding and correcting the root cause of a warning letter item can take longer than just 15 days. You also should note in the warning letter response the processes used for pinpointing the root cause.

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