FDA WARNING_LETTER - Branson Baking Co - February 11, 2014

The FDA conducted an inspection of Branson Baking Co. from January 31 to February 11, 2014, identifying significant deviations from Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These deficiencies render the firm's food products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Key CGMP violations include failure to adequately clean and sanitize equipment (21 CFR 110.80(b)(1)), facility construction preventing proper floor cleaning (21 CFR 110.20(b)(4)), cracked food contact surfaces (21 CFR 110.40(b)), and lack of designated sanitation supervision (21 CFR 110.80). Additional issues involved unsuitable employee garments (21 CFR 110.10(b)(1)), inadequate handwashing (21 CFR 110.10(b)(3)), and insufficient precautions to prevent food contamination (21 CFR 110.10(b)(9)). Some CGMP issues were previously noted by the Missouri Department of Health and Senior Services. Furthermore, the firm failed to register with FDA as a food facility, a prohibited act under section 415 and 301(dd) of the Act. Branson Baking Co. must take prompt corrective action, register its facility, and provide a written response within fifteen working days detailing corrective steps and supporting documentation. Failure to comply may lead to regulatory actions such as product seizure, injunction, prosecution, and re-inspection fees.