FDA WARNING_LETTER - Biondillo's Bakery - November 07, 2013

The FDA conducted an inspection of Biondillo's Bakery, LLC on October 23 and November 7, 2013, revealing serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110) and misbranding issues (21 CFR Part 101). Consequently, the firm's food products are deemed adulterated under Section 402(a)(4) of the Act and misbranded under Section 403. CGMP deficiencies included failure to reject contaminated food, protect against contamination, inadequate cleaning/sanitizing procedures, incompetent supervisory personnel, lack of chemical sanitation testing, plumbing issues, employee handwashing failures, absence of sanitary towel service, inadequate pest protection, improper waste disposal, insufficient lighting, and poor facility maintenance. Misbranding violations involved failure to declare major food allergens (wheat), incomplete ingredient declarations, lack of nutrition information (with a note on small business exemption eligibility), and omission of manufacturer/packer/distributor names on labels. Additionally, product labels had incorrect net weight declarations and inconsistent serving sizes. The FDA requires prompt corrective actions within fifteen working days, including documented evidence of corrections. Failure to comply may result in legal action, such as product seizure, injunction, and re-inspection fees.