FDA WARNING_LETTER - Societe Fromagere de Bouvron,

The FDA inspected Societe Fromagere de Bouvron's cheese processing facility in Bouvron, France, on December 5, 2011, and issued an FDA-483 for a serious violation of Current Good Manufacturing Practice (CGMP) regulations, 21 CFR Part 110. The primary deficiency identified was the firm's use of foam rubber-type material for pressure plates in cheese molding equipment that does not allow for adequate cleaning, violating 21 CFR 110.40(a). This condition renders the cheese products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they may be contaminated. The FDA found the firm's subsequent response regarding this equipment inadequate. Societe Fromagere de Bouvron must respond within thirty working days, detailing specific corrective actions with supporting documentation, and provide a comprehensive description of their Mimolette cheese manufacturing process. Failure to adequately address these issues could lead to refusal of admission for imported cheese products into the U.S. under Section 801(a) of the Act, including detention without physical examination, and potential assessment of re-inspection fees.