Sugar Bakers, Inc. – FDA Warning Letter, Jan 4, 2012

On March 19, 2012, the FDA issued a Warning Letter to Sugar Bakers, Inc. following an inspection from December 21-22, 2011, and January 4, 2012. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering their food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions. Additionally, their Smith Island Cake and Caramel Apple Pecan Coffeecake products were found to be misbranded under Section 403 of the Act (21 U.S.C. § 343) and 21 CFR Part 101.

Key violations included: 1. **Insanitary Conditions (21 CFR 110.80(b)(2)):** Uncovered baked goods were stored under plastic containers and baking racks coated in filth. A trash can was too close to the mixer, and uncovered batter was stored near filthy containers. 2. **Improper Fan Placement (21 CFR 110.20(b)(6)):** Dirt/dust-coated fans were blowing air onto uncovered unbaked pie crusts, baked cakes, and a carrot cake, and a fan was stored on a baking rack used for cooling