FDA’s close-out process is a way for manufacturers who have been landed a warning letter to officially clear their name.
“If the agency can determine that a firm has fully corrected violations raised in a warning letter the agency will issue an official ‘close-out’ notice and post this information on the FDA web site. This will be an important motivator for corrective action by manufacturers,” explained FDA Commissioner Hamburg during a speech to the Food and Drug Law Institute last month.
Motivation to correct
FDA issues warning letters to food and supplement manufacturers or marketers if they have been found to violate the regulations governing these. Once companies have received a warning letter, they must respond within a given deadline – which can be as little as 48 hours – to indicate how they plan to rectify the noted violations.
Under the new program implemented this month, close-out letters can be issued if a firm passes FDA’s evaluation of corrective action. This applies only to letters issued on or after September 1 2009, and only once the corrective action had been completed and signed off by FDA, usually via a follow-up inspection.
So far, there have been 13 warning letters issued in September to date. Close-out letters have not been posted against any of the recorded cases – which is not unexpected within the short timeframe since the program’s implementation.
However, response letters to each of these cases are also absent. In fact, response letters are lacking from the vast majority of cases filed by FDA’s Center for Food Safety and Applied Nutrition (CFSAN) since 2001. Out of the 36 warning letters issued by CFSAN in 2009, only one it noted as having received a response.
To view warning letters on FDA’s website – and to read more about the close-out process – click here.
Enforcement plans
FDA’s close-out program is only part of the agency’s robust plans for improving enforcement. During her speech to the Food and Drug Law Institute, Commissioner Hamburg said the agency was implementing measures to ensure “swift”, “aggressive”, and “effective” enforcement of its regulations.
Six initial steps she highlighted as part of efforts to achieve this were:
- Set post-inspection deadlines for industry to react swiftly to inspection findings
- Work more closely with FDA’s regulatory partners to ensure rapid action is taken, especially when public health is at risk
- Prioritize follow-up warning letters and other enforcement actions
- Be prepared to take immediate action in response to public health risks
- Implement a warning letter close-out process