FDA WARNING_LETTER - Dutch Valley Food Development Inc. - August 04, 2011

The FDA inspected Dutch Valley Food Development, Inc.'s manufacturing facility in Myerstown, PA, from July 25 to August 4, 2011, and found significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These violations render the manufactured foods adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, due to preparation, packing, or holding under insanitary conditions that could lead to contamination or injury to health.

Specifically, the inspection revealed failures to adequately clean food-contact surfaces as required by 21 CFR 110.35(d). Observations included: * Inadequate cleaning procedures during product changeovers, leaving significant food debris from allergen-containing products (e.g., Coconut Macaroon Cookie mix with tree nuts, wheat, egg) on equipment before manufacturing non-allergenic products (e.g., All Purpose Seasoning, Homestyle French Onion Soup mix). * Failure to clean and sanitize shared equipment used for both allergenic and non-allergenic ingredients, resulting in extensive residual product buildup. * Food debris caked on sifter and transfer chutes after CIP procedures, prior to processing products with different allergen profiles. * Improper storage of cleaning utensils (e.g., a hand brush not cleaned/sanitized between uses, a paddle leaning on a refuse bag, food-