FDA WARNING_LETTER - Pharmalucence, Inc. - April 30, 2008

An FDA inspection of Pharmalucence, Inc. from April 7-30, 2008, revealed significant deviations from cGMP regulations (21 CFR Parts 210 and 211) for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Sterilization Process Deficiencies (21 CFR § 211.113(b)):** Failure to validate bacterial filtration retention for multiple aseptically filled products (e.g., CIS-PYRO, AN-DTPA, CIS-Sulfur Colloid), observed poor aseptic technique, inadequate validation of steam sterilization cycles (e.g., lack of steam penetration studies, no justification for worst-case loads, unvalidated load configurations), insufficient environmental and personnel monitoring (e.g., improper air sampler placement, unvalidated multi-location testing), un-evaluated microbiological burden from manual aseptic connections, and incomplete airflow pattern testing studies. 2. **Inadequate Quality Control Investigations (21 CFR § 211.192):** Failure to thoroughly investigate environmental/personnel monitoring excursions (e.g., lack of root cause analysis, delayed initiation) and insufficient investigation into sterility testing issues for Iobenguane Sulfate I 131 (MIBG) Injection. 3. **Container Suitability (21 CFR § 211.94(c)):** Unvalidated dep