FDA 483 - Pharmakon Pharmaceuticals, Inc. - March 16, 2016

The FDA Form 483 documents observations from an inspection of an outsourcing facility. Key issues identified include the failure to conduct appropriate laboratory testing for satisfactory conformance to final specifications, identity, and strength of active ingredients prior to drug product release. There was also a failure to thoroughly review unexplained discrepancies and out-of-specification results for batches or components, regardless of distribution status.

Significant deficiencies were noted in aseptic processing areas, including a lack of established, written, and followed procedures to prevent microbiological contamination of sterile drug products. Specific issues in aseptic areas involved inadequate systems for maintaining equipment, cleaning and disinfecting rooms, and monitoring environmental conditions. Scientific justification for disinfectant contact times was not provided. Personnel clothing was deemed inappropriate for duties performed. The air supply in aseptic processing areas was deficient, lacking proper HEPA filtration and positive pressure.

Further violations included the absence of laboratory testing for sterility and pyrogen-free requirements for each batch of sterile drug product. Operations involving penicillin were not performed in facilities separate from other drug products. Drug product containers and closures were not sterilized or processed to remove pyrogenic properties, and no documentation supported pyrogen-free status for syringe caps. The responsibilities and procedures of the quality control unit were not in writing and fully followed. Additionally, the facility's drug product labeling lacked required information, and a complete report of compounded products for the previous six months had not been submitted to the FDA.