Expert: Best Practices in 483 Responses Key to Avoiding Warning Letters
Best practices in writing Form 483 response letters could help manufacturers avoid FDA warning letters, a compliance expert says.
While there are no guarantees, a complete and comprehensive response that explains all corrective actions taken to address the FDA’s concerns can put observations to rest, says Elaine Messa, president of NSF Health Sciences Medical Devices. “If you respond adequately and comprehensively, what more can the agency ask for?” she says.
Companies often make the mistake of forgetting their audience, Messa says. Manufacturers must remember they aren’t just talking to the investigator who conducted the inspection; they’re also talking to compliance directors at the FDA branch office and possibly at CDRH.
The distinction is important because manufacturers need to fully answer all observations in their Form 483 response, Messa says. Using shorthand that assumes the reader knows what was discussed during the inspection might cheat a devicemaker out of a chance to provide context.
Inspection History a Factor
Messa, a former director of the FDA’s Los Angeles district office, says the manufacturer’s description of the corrective action plan should be detailed and show that the company’s efforts to comply went beyond addressing the specific observations. For example, if a Form 483 mentions a quality systems problem in one division, the company may want to demonstrate that it looked at its quality systems throughout the entire company and took any required corrective actions.
If that step isn’t taken, the FDA will often come back to inspect other divisions in a cycle that can lead to multiple warning letters, Messa says.
A manufacturer’s inspection history is also a crucial factor in whether or not they get a warning letter, Messa warns. A company that has never had a compliance problem is much more likely to resolve a Form 483 based on its response letter than a company with recurrent issues.
If a warning letter is issued, the manufacturer should work with legal counsel and communications staff to determine how and whether to address the problems in the media, Messa says. The FDA publicly posts warning letters, while Form 483s can be requested under the Freedom of Information Act.
Transparency on the Rise
Most companies choose to keep quiet about 483s and warning letters unless they need to file a report with the Securities & Exchange Commission, but that may not be the best path, Messa says. Releasing positive information about the FDA action and ongoing corrective efforts might help prevent damage if a competitor is using a warning letter to recruit clients, she notes.
Messa says that while more warning letters are citing inadequate 483 response, there doesn’t seem to be any fundamental change either in FDA enforcement tactics or in devicemaker response. Rather, she believes the citations stem from the FDA’s ongoing push for greater transparency.
“In the past, devicemakers would have just gotten the warning letter, with no evidence on what the inadequacies are,” she says. “Now the FDA has taken initiative to provide more information.”
Messa will speak in more depth on warning letter and Form 483 best practice responses at FDAnews’ 9th Annual FDA Inspections Summit, Oct. 22 to 24, at the Doubletree Bethesda Hotel in Bethesda, Md. The session is scheduled for Friday, Oct. 24, from 9:45 to 10:15 a.m.
She will also participate in a panel discussion of former FDA staff on Thursday, Oct. 23, from 2:00 to 3:30 p.m. View more information at www.FDAInspectionsSummit.com. — Elizabeth Orr
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