Seoul Trading Inc – FDA Warning Letter, Oct 23, 2009
On October 20, 21, and 23, 2009, the FDA inspected a food storage, repacking, and importer facility at 1610 Boundary Road, Auburn, Washington. The inspection revealed serious deviations from Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110) for foods, causing products like rice, beans, and spices to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions.
Significant CGMP violations included: 1. **Pest Control (21 CFR 110.35(c)):** Failure to exclude insects and rodents, evidenced by numerous live and dead moths, larvae, pupae, fruit flies, grain beetles, and rodent excreta throughout the warehouse, including on and near food products. 2. **Food Storage (21 CFR 110.93):** Failure to protect food from contamination, observed by gasoline containers and joint compound stored near cased food. 3. **Pest Protection (21 CFR 110.20(b)(7)):** Inadequate screening, with gaps in bay doors. 4. **Equipment Storage (21 CFR 110.20(a)(1)):** Improper storage of unused equipment and miscellaneous items creating pest harb
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