Tuesday, April 24, 2012

FDA Warning Letters for April

Here is the letter to: Societe Fromagere de Bouvron:  

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.