FDA WARNING_LETTER - Atlantic Bakery Ltd. d.b.a. Old School Bakery - February 05, 2019

The FDA issued a Warning Letter to Atlantic Bakery Ltd. (d.b.a. Old School Bakery) following a December 2018 to February 2019 inspection of their Delray Beach, FL facility, which produces Ready-to-Eat (RTE) bakery products. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117), leading to adulterated food products under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Additionally, several RTE bakery products were misbranded under 21 U.S.C. § 343, violating 21 CFR Part 101, Food Labeling Regulation.

Key violations included the failure to prepare and implement a food safety plan (21 CFR 117.126(a)(1)), conduct a comprehensive hazard analysis (21 CFR § 117.130(a)) for hazards like allergens, environmental pathogens, vegetative pathogens, and mycotoxins, and implement preventive controls (21 CFR § 117.135(a)) with associated monitoring, corrective action, and verification procedures (21 CFR §§ 117.140 -117.165). CGMP violations involved failure to maintain a clean plant (21 CFR § 117.35(a)), inadequate contamination precautions (21 CFR § 117.80(a)(4)), and improper equipment maintenance (21 CFR § 117.40).

Misbranding violations encompassed failure to declare major food allergens (21 U.S.C. § 343(w)), bear the common name of the food (21 CFR 101.3), declare all ingredients (21 CFR 101.4), include the place of business (21 CFR 101.5(a)), state net quantity of contents (21 CFR 101.7), and include a Nutrition Facts label (21 CFR 101.9). The firm's March 1, 2019, response was deemed inadequate, particularly regarding specific labeling corrections. The FDA requires a written response within 15 working days detailing corrective actions, with potential regulatory actions like seizure, injunction, and re-inspection fees for non-compliance.