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

People's Custom Rx and Clinical Care, LLC, a producer of sterile drug products, underwent an FDA inspection from June 25 to July 2, 2018. The inspection identified several critical deficiencies in their manufacturing processes. Key observations included significant lapses in aseptic processing, where an operator was seen violating cleanroom protocols by exposing skin within the ISO 5 area and failing to re-sanitize gloved hands after exiting this critical zone. A major concern was the complete absence of endotoxin testing for numerous intrathecal drug products and their non-sterile starting materials or stock solutions, raising serious safety questions for dispensed medications. Furthermore, the facility exhibited failures in its environmental controls, specifically non-functional magnahelic gauges intended to monitor differential pressure between controlled cleanroom environments, observed during active sterile drug production. Disinfection procedures were found to be inadequate, lacking documented contact times for disinfectants and substantiation for current practices. Lastly, the company's depyrogenation process for glassware, essential for sterile product manufacturing, was unverified, and the equipment was improperly located, necessitating transfer through less controlled areas. These observations require a comprehensive response from People's Custom Rx and Clinical Care, LLC to ensure compliance with quality and safety standards for sterile drug production.