FDA 483 - Triangle Compounding Pharmacy Inc - March 01, 2013

The FDA Form 483 details significant deficiencies at a pharmaceutical compounding facility. The firm failed to thoroughly investigate unexplained discrepancies and out-of-specification results, specifically for sterility failures of Sodium Bicarbonate 8.4% PF Inj and Avastin 2.5 mg. Initial sterility failures were not attributed to laboratory error or sample handling, yet re-testing led to lot release without root cause determination or full documentation. Distributed lots included Avastin Lot 77711-LG4973 and Sodium Bicarbonate Lot 11035-29. Formal procedures for handling out-of-specification results are absent, and existing policies for outside lab testing and skip lot testing permit re-tests or process alterations without requiring root cause analysis.

Sterilization processes lack validation for products like Bupivacaine, Cyclosporine, Triamcinolone Hexacetonide, Hydroxyprogesterone Caproate, and Phenol Oil, as well as instruments and containers. The environmental monitoring program for ISO 5 cleanroom areas is inadequate, with deficient process simulation testing, insufficient surface sampling in adjacent ISO 5 areas, improper incubation for fungal detection, and infrequent sampling. Viable air sampling procedures were not followed, with missing control plates and unexposed plates in required rooms. Daily environmental and personnel monitoring is not performed during routine processing, and personnel gowning is not monitored. Unidirectional airflow in ISO 5 areas has not been confirmed via