FDA WARNING_LETTER - Fresh Farms LLC - November 11, 2021

On April 19, 2022, the FDA issued a Warning Letter to Fresh Farms LLC following an inspection from November 8-11, 2021, at their Las Vegas, NV facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products, including OTC Hand Sanitizer, adulterated under 21 U.S.C. 351(a)(2)(B).

The FDA found Fresh Farms' November 23, 2021, response to the Form FDA 483 inadequate due to a lack of supportive documentation and evidence of corrective actions, contradicting their claims of CGMP compliance.

Key violations include: 1. **Failure to establish an adequate quality unit (21 CFR 211.22(a) and 211.22(d))**: The firm lacked written procedures for the quality unit, product specifications, and proper documentation of batch reviews before release. 2. **Failure to test components (21 CFR 211.84(a))**: Fresh Farms did not sample, test, or examine incoming raw materials, including ethanol (an API), for their hand sanitizer, despite stating a customer was responsible for sourcing. This includes critical testing for methanol contamination. 3. **Failure to perform release testing (21 CFR 211.165