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FDA Releases Q&A for Preventive Controls for Animal Foods

  • In light of the approaching September 17, 2018 compliance date for small animal food businesses (i.e., those with less than 500 full-time equivalent employees) to comply with Hazard Analysis and Risk-Based Preventive Controls (HARPC) rules, FDA has released a Q&A document concerning what to expect in the near term regarding FDA enforcement and inspections.

  • The Q&A explains that, unlike HARPC for human food, FDA decided to stagger the compliance dates for HARPC and related Current Good Manufacturing Practice (CGMP) rules for animal food because there had not been longstanding CGMPs for the animal food industry.  FDA wanted to give industry time to focus solely on the foundation of CGMPs before imposing more onerous HARPC requirements.  FDA states that it will not conduct regulatory inspections for small businesses to evaluate compliance with HARPC requirements until the fall of 2019 in light of industry feedback that more time and technical assistance is needed to comply.

  • Of course, FDA will conduct inspections of small businesses “for-cause” before the fall of 2019 if, for example, a facility has a history of violative product or environmental samples, there is a recall, there are significant observations made during a previous inspection, or the facility is the subject of FDA or state enforcement action.  FDA’s delay of routine inspections should not be seen as a delay in the HARPC compliance date for small businesses, which remains September 17, 2018.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...