Inspections, Compliance, Enforcement, and Criminal Investigations
Societe Fromagere de Bouvron, 4/11/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD|
APR 11, 2012
VIA OVERNIGHT DELIVERY
Mr. Bruno Scotto, Plant Director
Societe Fromagere de Bouvron,
Route de Fay-de-Bretagne, BP 7,
44130 Bouvron, France
Reference No.: 291657
Dear Mr. Scotto:
The U.S. Food and Drug Administration (FDA) inspected your cheese processing facility located at Route de Fay-de-Bretagne, BP 7, 44130 Bouvron, France on December 5, 2011. During that inspection, we found that your firm had a serious violation of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Parts 110). This inspection resulted in FDA's issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection which listed the deviation found at your firm. Upon request from our office via email on March 15, 2012, you submitted testing records and a picture of the equipment used as a pressure plate. We have assessed that response and find it inadequate to alleviate our concerns with that piece of equipment. Failure to comply with the requirements of 21 CFR 110 renders your cheese products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) in that they have been prepared, packed, or held under insanitary conditions whereby the cheese may have been contaminated with filth or may have been rendered injurious to health. You may find the Act and FDA's regulations through links in FDA's home page at www.fda.gov.
Your firm's significant deviation continues to be as follows:
Your firm does not use plant equipment materials, namely the foam rubber-type material used with the pressure plates, that allow for adequate cleaning to comply with 21 CFR Part 110.40(a). Specifically, the pressure plates that are used to compress cheese curds within the equipment used to form the cheese (i.e., the cheese mold) have lower pad surfaces that are made of a foam rubber-type material in which our investigator observed small pores. These pads make contact with the top of the cheese as pressure is applied. The top of the equipment is made, in part, of a fine screen material, thus exposing the cheese curds within the equipment to potential microbial contamination from the foam rubber-type material underneath the pressure plates. Although you conduct periodic testing for Listeria spp. in your cheese products, you are still required under the CGMP regulations to only use materials that can be adequately and suitably cleaned.
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 further correct this violation. You should include in your response documentation that would assist us in evaluating your correction. If you cannot complete this correction within thirty (30) days; you should explain the reason for your delay and state when you will correct any remaining violation. In addition to the information above, we also ask that you send us a detailed description of your Mimolette cheese. During our inspection, this cheese was not being manufactured and thus our investigator was unable to observe its manufacturing and storage processes. Please include in a description the inoculations or other additions used for flavor or any other purposes at every stage of the cheese process.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your imported cheese products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts which can be found on FDA's web site at: http://www.fda.gov/Forlndustry/lmportProgram/ImportAlerts/default.htm.
This letter may not list all the violations at your facility. You are responsible for ensuring that you firm operates in compliance with the Act, the CGMP regulation (21 CFR Part 110), and other applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the U.S. Food and Drug Administration, Attention: Carol D'lima, Office of Compliance, Division of Enforcement, Food Adulteration Assessment 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. D'lima at (240) 402-2033 or via email at Carol.Dlima@fda.hhs.gov.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition