FDA WARNING_LETTER - Aspen Pharmacare Holdings Limited - September 17, 2024

The FDA issued a Warning Letter to Aspen SA Sterile Operations (Pty) Ltd. following an inspection from September 9-17, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Laboratory Controls (21 CFR 211.160(b)):** Failure to establish appropriate specifications and test sterile OTC drug products for impurities at release and throughout expiry. The firm's health hazard evaluation for impurity levels was deemed inadequate, and a similar deficiency was noted in a 2016 inspection. 2. **Failure to Prevent Microbiological Contamination (21 CFR 211.113(b)):** Observed poor aseptic practices in ISO 5 areas, including recurrent contamination events in media fills attributed to poor aseptic behavior, and inadequate disinfection procedures. Smoke studies did not demonstrate unidirectional airflow, and cleanroom/aseptic processing line designs posed fundamental contamination risks. 3. **Inadequate Computer System Controls (21 CFR 211.68(b)):** Production and Quality Units failed to review electronic raw data and audit trails for data integrity prior to batch release, with operators printing passing results after multiple failed filter integrity tests without recording failures. 4. **Inadequate Environmental Monitoring (21 CFR 211.42(c)(10)(iv)):** Failure to