DEPARTMENT OF HEALTH & HUMAN SERVICES
March 29, 2012
VIA OVERNIGHT DELIVERY
Mr. Pascal Jacquin, CEO
P. Jacquin et Fils
9 Route de Meusnes,
La Vernelle, France
Reference No.: 288800
Dear Mr. Jacquin:
We inspected your soft cheese manufacturing facility, P. Jacquin et Fils, located at 9 Route de Meusnes, La Vernelle, France, on December 15-16, 2011. During that inspection, we found that you had serious violations of the current Good Manufacturing Practice (cGMP) regulations for food manufacturers as described in Title 21, Code of federal Regulations, Part 110. Accordingly, your cheese products are adulterated, in that they have been prepared packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and the cGMP regulations through links in FDA’s home page at www.fda.gov.
That inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, listing one deviation found at your firm at the conclusion of the inspection.
We acknowledge that you responded via email on December 30, 2011. Your response to the FDA-483 included a description of the corrective action and additional supportive documentation. Our review of the documentation revealed that the response adequately addressed the identified FDA-483 observation. However, during our review of the inspection findings, we noted the following outstanding issue that requires corrective action:
- Failure to conduct food manufacturing under conditions and controls as are necessary to minimize the potential for the growth of microorganism as required by 21 CFR 110.80(b)(2). During the inspection, investigators noted the failure to properly locate the flow diversion valve (FDV) in the pasteurizer. The FDV is located after the cooling section of the pasteurizer, which can cause the contamination of the post-heating regeneration section, the cooling section, and associated piping with under-pasteurized milk in the event of a divert flow situation. FDA recommends relocating the FDV to a point at the end of the holding tube and before the pasteurized side of the regeneration section. If this correction cannot be addressed immediately, we recommend that you shut down the pasteurizer after a divert flow situation and conduct a full clean-in-place (CIP) method of cleaning, followed by a sanitizing cycle before resuming pasteurization operations. If you have data to show that you have verified that your system, as currently designed, is appropriate to minimize the potential for growth of microorganisms, please submit the data as part of your response to this letter.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with all applicable parts of the Act and regulations, including the current Good Manufacturing Practices regulations (21 CFR Parts 110).
You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. Your response should include documentation that would assist us in evaluating your corrections. If you cannot complete all corrections within 30 days you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the U. S. Food and Drug Administration, Attention: Maria Lau, Office of Compliance, Division of Enforcement, Food Assessment Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Ms. Maria Lau at (240) 402-2033 or via email at Maria.Lau@fda.hhs.gov.
Jennifer A. Thomas
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition