Edge Pharma, LLC – FDA 483, Nov 30, 2021

The FDA Form 483 inspection revealed numerous deficiencies at a drug manufacturing facility, particularly concerning sterile drug production. The facility's buildings are not maintained in good repair, with issues like missing caulking, unsealed holes, stained ceiling tiles, unknown residue on air ducts, black mold in the warehouse, and damaged baseboard trim. Vermin presence was noted throughout the facility.

The firm failed to properly maintain ISO-5 biological safety cabinets and ensure clean conditions for hazardous drug production. There is no formal mechanism to escalate facility issues. Investigations for unexplained discrepancies, batch failures, out-of-specification (OOS) results, customer complaints, microbiological environmental excursions, and mold trends were inadequate or not conducted.

Aseptic processing areas are deficient in cleaning and disinfection systems. Disinfectant efficacy studies were inadequate, and the firm lacks data on cleaning agent residue removal. Sterility testing procedures are not followed, and the program is inadequate, lacking appropriate controls. The media fill program is insufficient, not performed in the ISO-7 cleanroom for hazardous drugs, and does not document common interventions. Approximately 31% of media fill studies showed contamination.

Environmental monitoring trend evaluation is inadequate, and procedures are not followed. Sterile wipes are not protected from contamination. Smoke studies failed to demonstrate unidirectional airflow and did not include material transfers. Airflow patterns in ISO-5 areas are turbulent. The cleanroom air delivery systems and HVAC are inadequate, leading to mold recoveries and influx of lesser