FDA WARNING_LETTER - JFD Enterprises Inc - August 04, 2009

The FDA issued a Warning Letter to JFD Enterprises Inc. t/a Antonio's Bakery following an inspection in July and August 2009. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), causing food products to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions. Additionally, products were found misbranded under Section 403 of the Act, violating food labeling requirements (21 CFR Part 101). Key CGMP deficiencies included inadequate pest control, insufficient space for sanitary operations, improper raw material storage, and inadequate cleaning and maintenance of equipment and food-contact surfaces. Labeling violations encompassed failure to declare major food allergens, common or usual names of ingredients, the common or usual name of the food, manufacturer/distributor information, and accurate net contents. The FDA requires the firm to promptly investigate and correct all violations, implement preventive procedures, and respond in writing within fifteen working days with a detailed corrective action plan and timeline. Failure to comply may result in regulatory actions such as seizure or injunction.