FDA WARNING_LETTER - gold coast distributors inc. - May 27, 2022

The FDA inspected the ambient and frozen warehouse and re-packing facility at 2325 W. Charter Way, Stockton, CA, from May 09-27, 2022. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117). Filth samples collected showed rodent, insect, or cat filth throughout the facility, leading to a determination that food products were adulterated under 21 U.S.C. § 342(a)(4).

Violations included failure to exclude pests (21 CFR 117.35(c)), with observed rodent, insect, and animal activity, structural deficiencies, and harborage areas. FDA sample analysis confirmed contamination with rodent/mouse hairs, cat hair and urine, gnaw marks, and various insect stages. The firm's June 7, 2022, response regarding pest control and cleaning was deemed inadequate due to lack of documentation and confirmation of promised actions.

Further violations included failure to properly store equipment, remove litter and waste, and cut weeds/grass (21 CFR 117.20(a)(1)), with food products slated for destruction found outside and numerous rodent excreta pellets (REPs) observed. The firm's response lacked sufficient documentation. The facility also failed to maintain a clean and sanitary condition (