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Avoiding Warning Letters


Posted by mddiadmin on February 1, 2002

Originally Published MDDI February 2002

HELP DESK

John Lincoln

How can my company avoid receiving an FDA warning letter after we have been issued Form 483?

FDA-regulated companies frequently receive warning letters after the completion of a GMP compliance audit and the issuance of the FDA Form 483. Many of these instances could have been avoided. Obviously, the best way to avoid receiving a letter is to be in compliance with defined regulations. But even if 483 observations are received, there are methods to reduce the chance of receiving a follow-up warning letter.

Such methods may include:

  • Developing an active company compliance culture, and conveying that attitude to the investigator.
  • Correcting most observations—if not all—while the FDA investigator is still on-site. Ensuring that any remaining issues are in the process of being addressed, and that this is communicated to the investigator in writing before or during the close-out meeting—and before FDA's establishment inspection report is completed.
  • Ensuring that senior management is actively involved in the initial meeting, during the audit, in the final meeting, and in all subsequent communication with the agency.
  • Ensuring that all communication with the investigator and the agency is professional, that issues are satisfactorily addressed, and that proof of that is provided, including copies of the final, signed-off documents.
  • Seeing that promised action is taken and documented, and that copies are provided to the agency.
  • Ensuring that responses are timely. It is advisable to communicate frequently (monthly or quarterly).
  • Ensuring that the initial response is immediate, indicating the completed corrective action and the timelines for action in process.

There are some problems for which nothing can prevent the issuance of a Warning Letter. These would include reoccurring observations for the same problem, promised action not taken, operating with a lack of control, a poor past-compliance history, etc.

Sometimes the attitude senior people convey to the investigator can almost guarantee a warning letter. A few wrong responses: "It costs too much to implement that"; "Senior management is too busy"; "That's the responsibility of our QA manager"; and "We don't know (and aren't going to quickly find out)." Of course, if the company conveys the impression that it's out of control, or that management is not fully involved, that compliance is only a middle-management responsibility, then no matter what the response, a warning letter will be forthcoming.

If in doubt about the strategy to pursue, there are professional organizations and consultants who have been down this road before and can assist in developing an action plan and timeline.

What if your company has already received a warning letter? The points above still apply. An immediate effort should be made to respond to each issue on the 483 and in the warning letter. Tie each response to the specific observation—by number, reference, or quote.

Always, the best defense is avoidance through active compliance. But if a letter is received, immediate and periodic communication with the agency, supported with proof of compliance, will minimize the negative affects of regulatory action. If this is done while bringing the company quickly back into compliance, also it may provide the RA/QA function with new-found credibility and support from senior management.

John Lincoln is a principal at J. E. Lincoln and Associates, a consulting company serving industries regulated by FDA. Lincoln specializes in project management, product-to-market issues, defect reduction, cycle time reduction, ERP, quality management systems, and regulatory affairs.

Copyright ©2002 Medical Device & Diagnostic Industry


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