FDA WARNING_LETTER - K & B Company, Inc - May 15, 2017

An FDA inspection of K & B Company Inc. in Gallup, NM, from May 8-15, 2017, revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These conditions render the firm's bakery products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions. Key deficiencies included failure to manufacture, package, and store foods to minimize microbial growth and contamination (110.80(b)(2)), plant construction not preventing drip or condensate contamination (110.20(b)(4)), and inadequate pest protection (21 CFR 110.20(b)(7)). The inspection also found that personnel responsible for sanitation lacked adequate education and experience (21 CFR 110.10(c)), and food handlers had not received appropriate training in food handling techniques (21 CFR 110.10(c)). Furthermore, the firm's cleaning and sanitizing procedures for equipment and utensils were inadequate (21 CFR 110.35(d)(5)). Many of these violations were repeat observations from previous inspections in October 2010 and May 2014, indicating a persistent lack of corrective action. The FDA requires the firm to take prompt action to correct these violations and establish preventative procedures. A written response detailing corrective steps, recurrence prevention, and supporting documentation is required within fifteen business days to avoid potential legal action, including seizure or injunction.