FDA 483 - People's Custom Rx and Clinical Care, LLC - July 02, 2018

An FDA inspection conducted from June 25 to July 2, 2018, at People's Custom Rx and Clinical Care, LLC, a producer of sterile and non-sterile drug products, revealed several significant deficiencies. The observations highlight concerns regarding the firm's adherence to quality standards for drug manufacturing. Key issues identified included poor aseptic processing techniques, where an operator's gloved hands left the ISO 5 area without re-sanitization and exposed skin entered the critical zone. The firm also failed to adequately test all lots of intrathecal drug products for endotoxin prior to release, and stock solutions used for these products were not tested for sterility or endotoxin after repeated use. Environmental monitoring was found deficient, with pressure differential gauges between controlled areas not functioning or reading "0" during drug preparation. Furthermore, disinfectant procedures lacked specified contact times and supporting documentation. Finally, the depyrogenation process for glassware used in sterile product manufacturing was unverified, and the equipment's placement in an ISO 8 anteroom introduced potential contamination risks during transfer to the ISO 7 cleanroom. These observations necessitate prompt corrective actions to ensure the safety and quality of their drug products in compliance with regulatory expectations.