FDA WARNING_LETTER - Queseria Chipilo, Inc. - November 08, 2010

The FDA conducted multiple inspections of Queseria Chipilo, Inc. between August and November 2010. Laboratory analysis confirmed the presence of Listeria monocytogenes in the firm's ready-to-eat Oaxaca String Cheese, rendering it adulterated under Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act. Environmental swabs also detected L. monocytogenes in seven areas, including food and non-food contact surfaces, with PFGE patterns identical to the finished product isolate, indicating widespread contamination. The inspections revealed significant Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 110, leading to adulteration under Section 402(a)(4). Deficiencies included failure to maintain sanitary facilities and equipment (21 CFR 110.35(a)), ensure corrosion-resistant food-contact surfaces (21 CFR 110.40(a)), adequately install plumbing and drainage (21 CFR 110.37(b)(3), (b)(4)), and enforce proper employee hygienic practices (21 CFR 110.10(b)). Additionally, food-contact surface seams were not smoothly bonded (21 CFR 110.40(b)), raw materials were improperly stored (21 CFR 110.80(a)(5)), and employee training documentation was lacking (21 CFR 110.10(c)). The firm also failed to implement its consultant's GMP and Listeria sampling programs. Despite voluntary closure, product embargo, and recall, follow-up inspections showed inadequate corrective actions, with CGMP violations persisting. The FDA requires prompt written response within 15 working days, outlining specific corrections, supporting documentation, and timelines for any outstanding issues, emphasizing the need for lasting corrective action to prevent further regulatory action.