• On July 26, 2018, FDA posted its first Warning Letter citing Kerry, Inc. for alleged violations of the Hazard Analysis and Risk-Based Preventive Controls (HARPC) and Current Good Manufacturing Practice (CGMPs) provisions at 21 CFR Part 117. While FDA has cited violations of the revised CGMP regulations in prior Warning Letters, this appears to be the first Warning Letter that addresses violations of the HARPC requirements.
  • Based on the results of the inspection and analytical results from positive Salmonella environmental samples, FDA determined that the cereal produced at the facility is adulterated under Section 402(a)(4) of the Food, Drug and Cosmetic Act because it was prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health. Kerry’s own tests returned repeated positive results for Salmonella but it continued to produce and ship cereal. It is important to note that failure to comply with CGMP and HARPC requirements does not result in adulteration per se, but it is a prohibited act.  FDA cited the following CGMP and HARPC violations:
  1. “Your hazard analysis did not identify a known or reasonably foreseeable hazard for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control as required by 21 CFR 117.130(a)(1).”
  2. “You are required to identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 U.S.C. §§ 342 or 343(w)) to comply with 21 CFR § 117.135(a)(1).”
  3. “You did not implement written corrective action procedures that must be taken if preventive controls are not properly implemented to comply with 21 CFR 117.150(a)(1) and (d).”
  4. “You did not verify that your sanitation preventive controls are consistently implemented and are effectively and significantly minimizing or preventing a hazard with environmental monitoring as required by 21 CFR § 117.165(a).”
  • FDA’s Warning Letter signals that FDA will continue to focus on violations of the CGMP and HARPC provisions.  We will continue to monitor and report on FDA’s enforcement activities as they relate to HARPC and other food safety related issues.