FDA WARNING_LETTER - Da'Vita Foods Company, Inc. - July 24, 2013

On July 15-17 and 24, 2013, the FDA inspected Da'Vita Foods Company, Inc., a bakery in Hagerstown, MD, and identified serious violations of Good Manufacturing Practices (GMPs) under 21 CFR Part 110. These deficiencies render the firm's bakery products adulterated per Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions. Key violations included inadequate precautions to protect food from extraneous material, improper equipment storage, and pest harborage (21 CFR 110.20). The firm failed to clean frequently, exclude pests, maintain facilities, and properly store cleaned equipment (21 CFR 110.35). Other issues involved inadequate plumbing (21 CFR 110.37(b)(2)), failure to protect against metal inclusion and maintain equipment (21 CFR 110.80), and poorly maintained food contact surface seams (21 CFR 110.40(b)). Personnel practices were also deficient, including not wearing beard covers, drinking near exposed food, and inadequate personal cleanliness (21 CFR 110). The FDA noted a repetitive history of violations, with some proposed corrective actions in the firm's August 1, 2013, response deemed inadequate or requiring clarification. Da'Vita Foods must respond within fifteen working days, detailing specific corrections, including documentation like HACCP plans. Failure to correct violations may lead to product seizure, injunction, and re-inspection fees.