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FDA Takes First Step in Enforcement Plan; New Timeline Effective Sept. 15

Aug 17, 2009

The Food and Drug Administration wasted no time in taking steps to implement the new enforcement plan announced earlier this month by Commissioner Margaret Hamburg. The first action, announced in the Federal Register last week, establishes a timeframe of 15 business days for companies to submit responses following an FDA inspection. It will take effect September 15.

Under the current practice, no time frame had been established and FDA indicated that at times responses took months to be completed. Now companies will have 15 business days to respond to inspection findings before the agency issues a warning letter or takes other enforcement action. According to FDA, the new procedure will encourage prompt voluntary compliance and streamline the process of sending the warning letters, when necessary.

The process of responding, however, will remain the same. Once the agency completes an inspection, the company will receive FDA Form 483, a report that details any objectionable conditions or violations that were observed during the inspection. The company then may respond with objections to the observations or explanations about any corrective actions taken.

"Dairy processors must be cognizant that they will generally have only 15 business days to respond to FDA's inspection observations before FDA decides if it will issue a warning letter," said Clay Detlefsen, IDFA vice president of regulatory affairs. "While a response is not required to be filed within 15 days, IDFA believes as a general rule doing so will be in your best interests."

The new enforcement plan includes five additional steps:

  • FDA to speed the warning letter process. FDA will limit review of warning letters by the Office of Chief Counsel to those that present significant legal issues.
  • FDA to work more closely with its regulatory partners. In some cases, such as with food safety issues, state, local, and international officials can act more quickly than the FDA. When public health is at risk, the agency will coordinate with its regulatory partners to take rapid action.
  • FDA to set priorities for follow-up on warning letters and other enforcement actions. FDA will work quickly to assess and follow up on corrective action taken by industry after a warning letter is issued or major product recall occurs.
  • FDA shall be prepared to take immediate action in response to public health risks. To better protect the public health, the agency is prepared to act more quickly and aggressively to deal with significant public health concerns and violations. Such actions may occur before a formal warning letter is issued.
  • FDA to develop and implement a formal warning letter "close-out" process. 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 website.

For more information, contact Detlefsen at or (202) 220-3554.

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