FDA WARNING_LETTER - Evi Labs - January 15, 2025

The FDA inspected Evi Labs LLC in Medley, Florida, from January 9-15, 2025, and found significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated. The firm's January 30, 2025, response to the FDA 483 was deemed inadequate due to insufficient supporting documentation and evidence of corrective actions.

Key violations include: 1. **Failure to test drug products prior to release (21 CFR 211.165(a))**: Evi Labs released OTC drug products, including topical antiperspirants with aluminum chlorohydrate, without adequate strength and identity testing. For example, Zermat Kiwi Perfumado (lot 291023) exceeded the 25% aluminum chlorohydrate limit permitted by the OTC antiperspirant monograph (M019), and no investigation or action plan for violative product in commerce was provided. 2. **Inadequate laboratory controls (21 CFR 211.160(b))**: The firm failed to establish scientifically sound microbiological specifications for OTC drug products, setting limits significantly higher than USP guidance. While new limits were committed to, retrospective testing of previously distributed product was not. 3. **Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a))**: