FDA WARNING_LETTER - Eco Lips, Inc. - March 24, 2022

On September 20, 2022, the FDA issued Warning Letter WL 631629 to Eco Lips, Inc., following an inspection from March 22-24, 2022. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Stability Program (21 CFR 211.166(a)):** The firm failed to establish an adequate written testing program to assess drug product stability and determine expiration dates for OTC drug products. This is a repeat observation from 2019 and 2021 inspections. 2. **Failure to Investigate OOS Results (21 CFR 211.192):** The firm did not thoroughly investigate out-of-specification (OOS) assay results for several OTC drug product batches, retesting and releasing products without proper investigation. The firm committed to voluntarily recall affected batches. 3. **Lack of Process Validation (21 CFR 211.100(a)):** The firm failed to provide data demonstrating validated manufacturing processes for all OTC sunscreen drug products, with most groups lacking completed validation studies. This is a repeat observation from 2021. 4. **Inadequate Cleaning Validation (21 CFR 211.67(b)):**