FDA WARNING_LETTER - Schindler's Broad Run Cheese House, Inc. - December 16, 2010

The FDA inspected Schindler's Broad Run Cheese House Inc. from September 22 to October 13, 2010, and again on December 16, 2010. The inspection revealed serious deviations from 21 CFR Part 110, Current Good Manufacturing Practice (CGMP), leading to the adulteration of swiss cheese under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). The swiss cheese was also found to be misbranded under section 403 of the Act and 21 CFR Parts 101 and 133.

CGMP violations included: 1. Failure to maintain sanitary conditions and equipment repair (21 CFR 110.35(a)): Unmeasured, unlabeled acid cleaner poured into a balance tank; caustic cleaner drained onto the floor near cheese; employees using murky wash water without sanitizer for utensils; reddish slimy substance and black mold in brine tanks holding in-process cheese; chipped cement and peeling paint on walls, and black mold and condensate on the ceiling in the brine room. 2. Inadequate handwashing facilities (21 CFR 110.37(e)): No soap at handwashing sinks in the repackaging area or employee restroom; an employee used a scrubbing pad for hands that was also used for cleaning utensils in the utensil sink.

The letter acknowledged corrections observed on December