FDA WARNING_LETTER - Aurolife Pharma, LLC - February 12, 2020

The FDA issued a Warning Letter to AuroLife Pharma, LLC, following an inspection from January 13 to February 12, 2020, at their Dayton, New Jersey facilities. The letter identifies significant violations of current Good Manufacturing Practice (CGMP) regulations, rendering their drug products adulterated.

Key violations include: 1. **Inadequate OOS Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate out-of-specification (OOS) impurity results for olanzapine API and finished drug product. Initial OOS results were invalidated without sufficient root cause determination, and corrective actions for HPLC method issues were not timely implemented. The FDA found the firm's response and revised OOS procedure inadequate, requiring identification of impurities, a review of affected batches, a comprehensive assessment of laboratory practices, and a retrospective review of all invalidated OOS results. 2. **Facility Maintenance Failures (21 CFR 211.58):** The facility experienced multiple instances of water leakage in encapsulation and packaging areas, potentially exposing drug products to moisture. The firm failed to promptly address root causes and assess risks. The FDA requires a CAPA plan for vigilant operations management oversight and a retrospective review of potentially impacted drugs. 3. **Insufficient Cleaning Procedures (21 CFR 211.67(b)):** Visible powder residue was observed throughout the facility, indicating inadequate cleaning and