FDA WARNING_LETTER - Azteca Linda Corp - September 03, 2010

The FDA inspected Azteca Linda Corp. d.b.a. Queso El Azteca's cheese manufacturing facility in Brooklyn, NY, between June and September 2010. Environmental samples collected on June 7 and August 25, 2010, tested positive for *Listeria monocytogenes* (L. monocytogenes), a human pathogen. Nine swabs from June 7 and three from August 25 showed L. monocytogenes in areas like cracked floors, standing water, equipment surfaces, and cleaning tools. Pulsed Field Gel Electrophoresis (PFGE) analysis indicated a persistent, indistinguishable strain of L. monocytogenes, suggesting inadequate sanitation and established niche areas. The Rhode Island Department of Health also reported L. monocytogenes in finished Queso Fresco and Requeson products.

These findings, combined with observed Current Good Manufacturing Practice (CGMP) violations, render the ready-to-eat cheese products adulterated under 21 U.S.C. §342(a)(4). Specific CGMP violations included: 1. Failure to properly clean and sanitize food-contact surfaces (21 CFR 110.35(a)): An employee did not use sanitizer on bowls after cleaning with detergent, and a high-pressure hose used for cleaning near exposed product created aerosols. 2. Lack of effective hand sanitizing preparations (21 CFR 110.