FDA WARNING_LETTER - Zoka Coffee Company, LLC - April 22, 2011

The FDA inspected Zoka Coffee Company's Seattle facility from April 14-22, 2011, identifying serious Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 110), rendering their food products adulterated 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)):** Extensive rodent excreta pellets (REPs), gnaw holes, insect larvae, and live insects were found on green coffee bean bags in the storage area, and throughout the production room, training room, break room, and tea repackaging area. One live rodent was observed. 2. **Inadequate Pest Protection (21 CFR 110.20(b)(7)):** A 3/4-inch gap was observed under the main door leading outside. 3. **Employee Handwashing Deficiency (21 CFR 110.10(b)(3)):** An employee sneezed into their hand then touched the inside of a plastic bag for tea without washing hands. 4. **Improper Equipment Handling (21 CFR 110.80(b)(7)):** Plastic containers of roasted coffee were stored directly on the floor near REPs, and scoops with residue/tape were used or