FDA 483 - US Compounding Inc - March 27, 2014

An FDA Form 483 inspection revealed multiple deficiencies in the manufacturing of sterile drug products. The facility failed to ensure protective apparel was worn, as a technician had exposed skin in an ISO 5 laminar flow hood during Omnipaque setup. Procedures to prevent microbiological contamination were inadequate, with a technician unnecessarily hand-stoppering HCG/B12 vials in an ISO 5 hood.

Cleanliness was compromised, as ISO 5 laminar flow hoods contained white residue streaks, blotches, and amber residue on HEPA filters while sterile products were being produced. Container closure systems were deficient; finished Betamethasone vials were found soaking in an unvalidated solution without SOPs, risking contamination.

Sterility and pyrogen testing were non-conforming. The firm released multiple sterile lots using an unvalidated endotoxin test method by a contract lab, failing to provide product-specific dosing for maximum valid dilution calculation. Sterility testing suitability (USP <71>) was based on different products or formulations.

Drug product release lacked appropriate laboratory determination of conformance. No 100% visual or automated inspection of sterile finished products was documented, and no visual inspection procedure or technician training qualification existed.

Aseptic processing area cleaning and disinfection were deficient. Only one disinfectant ((b)(4)) was used in ISO 5 hoods, lacking a sporicidal agent. A pharmacy technician performed inadequate disinfection, only wiping the tabletop, ceiling, and sides, neglecting the stained back surface of