During a recent speech, the new FDA Commissioner, Dr. Margret Hamburg, announced a plan speed up enforcement activities, i.e., shorten the time from an inspection to a Warning Letter. The plan, scheduled for implementation beginning September 15, 2009, is to issue a Warning Letter for significant violations that may lead to enforcement action without taking into consideration information received after 15 days from the date of the FDA 483 (Report of Inspectional Observations).
In the past the FDA has delayed warning letters while it reviews information submitted by the firm. When the firm has made multiple submissions, sometimes over many months, the agency has reviewed them and postponed issuing a Warning Letter as a result. Under the new policy, if the FDA receives a response to the 483 within 15 business days, it will consider the response in the decision to issue a Warning Letter.
Information received after 15 business days will be reviewed as part of the response to the Warning letter.
You may review the new plan in two places.
- The Ombu Library contains a copy of the Notice from FDA
- You can review the official version at www.regulations.gov by entering Docket Number FDA-2009-N-0335.
You may read Dr. Hamburg’s remarks: Effective Enforcement and Benefits to Public Health, presented to the Food and Drug Law Institute on August 6, 2009 at