F.D.A. altering enforcement plans

by FoodBusinessNews.net Staff
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WASHINGTON — Effective Sept. 15, the Food and Drug Administration has created a 15-business day timeline for companies to submit responses following an inspection. The process of responding will remain the same.

Once the F.D.A. completes an inspection a company will receive a form 483 that will outline conditions or regulatory violations that require corrective action. Companies will have 15 business days to respond to the inspection findings before the agency issues a warning letter or takes other enforcement action.

Currently, there is no time frame for response and the F.D.A. has noted that at times responses took months to complete. The new protocol will lead to prompt compliance, according to the agency, and streamline the process of sending warning letters when necessary.

"Before issuing a warning letter, F.D.A. will generally allow 15 business days to provide a response to F.D.A. 483 observations," said the agency in a notice published in the Federal Register. "If we receive a response to F.D.A. 483 observations within 15 days after the F.D.A. 483 was issued, we plan to conduct a detailed review of the response before determining whether to issue a warning letter.

"If we issue a warning letter after reviewing a firm’s timely response, the warning letter will recognize receipt of the response and reply as to the apparent adequacy of the firm’s corrective actions set forth in the response."

If the F.D.A. receives a response to a form 483 more than 15 business days after it was issued, it does not plan to include a response regarding the adequacy of the actions taken. The agency said it will "plan to evaluate the response along with any other written material provided as the direct response to the warning letter."

The agency also highlighted in the Federal Register notice that it may issue warning letters at any time. The F.D.A.’s effort to alter its enforcement protocols follows a speech given by Margaret A. Hamburg, commissioner of the agency, on Aug. 6. In that speech, Dr. Hamburg said an effective enforcement strategy depends on several key elements, including the F.D.A.’s need to be vigilant, strategic, quick and visible.

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