FDA WARNING_LETTER - Capitol Cake Co. - May 30, 2008

The FDA conducted an inspection of Capitol Cake Co.'s food storage warehouse in Baltimore, Maryland, from May 12-30, 2008, revealing serious Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 110. The inspection documented insanitary conditions where ingredients and finished food products may have become contaminated with filth, rendering them adulterated per 21 U.S.C. 342(a)(4). Key violations included a failure to prevent pests (21 CFR 110.35(c)), evidenced by live and dead rodents, a live bird, and extensive rodent urine and excreta on products and materials. The firm also failed to provide adequate pest protection (21 CFR 110.20(b)(7)), with open loading dock doors, and neglected facility maintenance (21 CFR 110.35(a)), as seen by holes in walls and floors with associated rodent filth. The FDA acknowledged the firm's June 5, 2008 response, noting some corrective actions like product destruction and initial wall repairs, but emphasized that sealing holes with cement was incomplete and would be verified. Capitol Cake Co. is required to determine the root cause of the infestation, implement lasting corrective actions, and respond in writing within 15 working days with detailed documentation of all steps taken to address the violations, including plans for pest control and food protection. Failure to comply could lead to regulatory actions such as seizure or injunction.