FDA WARNING_LETTER - RDM Express Inc. - September 15, 2022

On December 12, 2022, the FDA issued a Warning Letter to a warehouse facility in San Francisco, CA, following an inspection from September 5-15, 2022. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) & Preventive Controls for Human Food regulations (21 CFR Part 117).

Key violations include: 1. **Seafood HACCP Deficiencies:** The firm failed to implement monitoring procedures for Herring Fillets in Oil, specifically regarding temperature checks during transit and continuous temperature monitoring in refrigerated storage. Thermometers used were not calibrated. Corrective actions for temperature deviations were deemed inappropriate, failing to address the root cause. These are repeat violations from a 2017 inspection. 2. **Insanitary Conditions/Pest Infestation:** Extensive evidence of rodent and insect activity was found throughout the facility, including numerous rodent excreta pellets, chewed packaging, nesting material, dead rats, and a strong urine odor. This violates CGMP requirements for pest exclusion (21 CFR § 117.35(C)) and renders food products adulterated under 21 U.S.C. § 342(a)(4). This is a repeat violation from a 2014 inspection. 3. **Lack of HAC