New FDA Regulations Require Companies to Respond to Inspection Violations Within 15 Days

Manufacturers now have 15 days to respond to inspection reports to avoid an FDA warning letter. The change is intended to help the agency be more effective in protecting the public and may help to weed out bad actors from legitimate industry. According to the FDA, warning letters will also be sent out in a more efficient fashion, since they no longer require clearance by the Office of Chief Council, unless there are “significant legal issues.” The FDA will no longer issue multiple warning letters to noncompliant firms before taking more significant actions according to FDA Commissioner Margaret Hamburg, and the FDA may move immediately without issuing formal warning letters. If there are “significant health concerns or egregious violations” that pose “an immediate threat to health.”

Source: (Aug. 24, 2009)