Apollo Health And Beauty Care, Inc. – FDA Warning Letter, Aug 16, 2019

The FDA issued a Warning Letter to Apollo Health and Beauty Care, Inc. on December 23, 2019, following an inspection from August 12-16, 2019. The inspection revealed significant violations of CGMP regulations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to calibrate and maintain equipment records (21 CFR 211.68(a))**: Discrepancies were found between HMI data and batch records, indicating operators did not follow instructions. The firm's response was inadequate, failing to establish root cause, assess the scope of discrepancies, or address quality unit oversight. 2. **Failure to establish adequate production and process control procedures (21 CFR 211.100(a))**: The firm lacked process validation for multiple drug products, a repeat observation from a December 2016 inspection. Operators failed to follow batch instructions or document deviations, and the firm did not assure that lengthy bulk hold times did not impact product quality. 3. **Failure to thoroughly investigate discrepancies or failures (21 CFR 211.192)**: Inadequate investigations were conducted for foreign particles in a lot and an OOS test result for low content. The firm's corrective actions were insufficient and did not include retrospective reviews or adequate CAPA. This was also a repeat observation from 20