FDA WARNING_LETTER - Mave Enterprises, Inc. - October 05, 2010
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The FDA conducted an inspection of Mave Enterprises, Inc.'s food storage and processing facility in North Hollywood, California, from September 27 to October 05, 2010. The inspection revealed serious violations of FDA's Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110), leading to the adulteration of food products like dry fruit, spices, and candy under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.
Key violations included: 1. **Pest Exclusion Failure (21 CFR 110.35(c)):** Rodent excreta pellets (confirmed rat/mouse) were found near various food products, including dried apricots, bubble gum, and candy. Live and dead insects (cockroaches, moths) and two dead rodents in a glue trap were also observed throughout the facility, including in the Spice Packaging Room and walk-in cooler. 2. **Improper Waste Disposal (21 CFR 110.37(f)):** An overflowing trash dumpster with food waste, including melting chocolates, was observed outside Unit E, creating an attractant for pests. This was noted as a recurring violation from a previous inspection. 3. **Inadequate Hygienic Practices (21 CFR 110.10(b)(3)):** An employee was observed re-packing ready-to
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