22. Recalls for Fiscal Year 2004 By FDA Center Source Of Data: Division of Compliance Management and Operations, OE Total Recalls = 4,670
23. Warning Letters for Fiscal Year 2004 By FDA Center Source Of Data: Division of Compliance Management and Operations, OE Total Warning Letters = 737
24. Seizures for Fiscal Year 2004 By FDA Center 7 2 1 Source Of Data: Division of Compliance Management and Operations, OE Total Seizures - 10
25.
Editor's Notes
Provide biographical sketch if necessary or desirable.
Although theoretically releasable immediately upon issuance, request is predicated on knowledge of the 483’s existence.
Personnel at firms can become as knowledge-able about the regulations as FDA investigators and will always have more knowledge about their own firm’s operations. If an observation seems inappropriate, the close-out is an opportunity for discussion. Turbo EIR is a mechanism for increased consistency and accuracy.
The Medical Device Warning Letter Pilot is no longer in effect (adequate response could previously obviate issuance of W/L).
Companies should feel free to challenge the inspectional team to explain the basis for the observation. Convincing information that invalidates the observation should result in its removal. Any such discussions should focus on issues and not descend to a personal level.
Warning Letter Reference Guide and Regulatory Procedures Manual define violations of regulatory significance as circumstances, which if uncorrected, would lead to enforcement action. Multiple Warning Letters are not to be issued.
It is imperative that you understand why FDA considers the GMP concerns significant. You will have provided written responses by the time of the meeting. Make sure FDA understands and accepts them. Ask FDA directly if you proposed corrections are adequate and if further regulatory action is contemplated. Do not conclude meeting until all FDA requirements are understood. Provide a written summary of the meeting to FDA,including any points of clarification and additional commitments. Regular follow-up can help convince FDA of the seriousness of your commitment. EXPECT A FOLLOW-UP INPSECTION FROM FDA.
If you need more time to complete a correction, ask for it. Citing poor training or similar common excuses can be perceived as a failure to address root causes. Inspectional observations should be significant. If you don’t understand the significance, ask. Have someone other than the person who prepared the response read it for clarity and accuracy. Claiming that other companies don’t get cited for the same thing may lead FDA to ask for names of specific companies. Don’t claim to make a corrections and then fail to do so.
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