What we do:

Time is of the essence!

Why we do it:

1. Collecting and analyze current and past warning letters, all 483 observations, internal audits, GMP documentation, and related evidence.

2. Draft a FDA Warning Letter Recovery Plan.

3. Issue and keeping current a punch list assigning what is to be done, when it is to be done, and who is to do it.

4. Serve as a liaison between the company and the FDA, discussing corrective actions, collecting FDA expert comments, responding to questions, and helping resolve problems.

5. Coordinate and work with the warning letter recovery team, other staff and the FDA representatives.

6. Research and provide applicable FDA regulations, guidance documents, notes and cases to support "appropriate" corrective actions.  This research is a key component of cost effective FDA warning letter recovery.

7. Assist in the preparation and review of all correspondence to the FDA.

8. Provide training for management and staff.

9. Conduct a complete quality system audit prior to FDA's follow-up inspection.

10. Coordinate and host FDA warning letter follow-up inspection.

11. Provide FDA warning letter recovery progress reports to management throughout the process.

The Help Desk addresses warning letter recovery with urgency.  All responsibilities are handled professionally, confidentially and efficiently.

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