FDA WARNING_LETTER - Chantel's Cakes & Pastries - January 06, 2011

The FDA inspected Chantel's Cakes & Pastries from November 30, 2010, to January 6, 2011, revealing serious insanitary conditions and violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). Consequently, the firm's bakery products are deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations include the failure to effectively exclude pests and protect food from contamination (21 CFR 110.35(c)), evidenced by widespread rodent excreta and dead rodents. The firm also failed to minimize waste as a pest attractant (21 CFR 110.37(f)) by not having a dumpster and storing garbage and unused equipment in the warehouse. Additionally, there was a failure to provide running hot water for cleaning (21 CFR 110.37(a)) due to a broken sink handle, and inadequate pest screening (21 CFR 110.20(b)(7)) with missing curtain panels and gaps in a bay door. Furthermore, the facility failed to register with FDA as required by section 415 of the Act and 21 CFR Part 1, Subpart H, which constitutes a prohibited act under 301(dd) of the Act. The FDA requires the firm to register within 30 working days and respond in writing within fifteen working days detailing corrective actions taken or planned to address all violations and prevent recurrence. Failure to comply may lead to regulatory actions such as seizure or injunction.