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IDFA Discusses Inspection Concerns with FDA Officials

Jan 17, 2018
John Allan, IDFA Vice President of Regulatory Affairs and International Standards

IDFA met last month with several top Food and Drug Administration officials, including Stephen Ostroff, M.D., deputy commissioner of the Office of Foods and Veterinary Medicine, and Susan Mayne, director of the Center for Food Safety and Applied Nutrition (CFSAN), to share concerns about FDA inspections of dairy food facilities under the new Preventive Controls for Human Food rule.

They discussed a variety of issues, including FDA investigator interpretations of draft guidance for the Preventive Controls for Human Food rule, requests for company information that is beyond the scope of FDA’s authority and the need for greater consistency between FDA investigators’ evaluations of facilities. In addition, they reviewed concerns and offered suggestions for improving FDA’s proposed pilot program for combining inspections of dairy processing facilities producing both Grade “A” milk products and non-Grade “A” foods and beverages.

“FDA welcomed the opportunity to hear from the industry and is very open to receiving additional feedback as FDA continues its roll-out of inspections and enforcement of the Preventive Controls for Human Food rule and other rules under the Food Safety Modernization Act,” said John Allan, IDFA vice president of regulatory affairs and international standards. “It is clear the agency is looking to be more consistent and efficient in carrying out its duties and IDFA is glad to be able to help.”

IDFA is working with its regulatory committees to collect and share more member examples, concerns and suggestions.

Members with questions may contact Allan at

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