FDA WARNING_LETTER - Panaderia El Angel - December 09, 2011

An FDA inspection of your Hispanic bakery in Arlington, Washington, conducted in November and December 2011, revealed serious Current Good Manufacturing Practice (CGMP) violations, rendering food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key CGMP deficiencies included failure to prevent contamination from production procedures (e.g., allergen cross-contamination, uncleaned equipment), maintain sanitary equipment and utensils, protect finished food from raw materials, handle work-in-progress to prevent contamination, store raw materials properly, ensure adequate employee handwashing, and enforce removal of hand jewelry. The facility also failed to maintain sanitary buildings and fixtures, with issues like missing ceiling tiles and cracked floor tiles. Additionally, a review of "Pastel 3 Leches" product labels identified multiple misbranding violations under Section 403 of the Act, including failure to declare major food allergens (wheat, tree nuts), common or usual ingredient names, net weight, and complete bilingual information. The label also incorrectly used "conservatives" instead of "preservatives." While some issues were reportedly corrected, a comprehensive written response detailing all corrective and preventive actions, with supporting evidence, is required within fifteen working days. Failure to comply may result in regulatory actions like seizure or injunction and re-inspection fees.