FDA 483 - PharmScript, LLC - August 07, 2018

PharmScript, LLC, a producer of sterile and non-sterile drug products, underwent an FDA inspection from July 30 to August 7, 2018. The inspection revealed critical observations concerning aseptic processing and contamination control, indicating potential deviations from regulatory standards. Key issues included the inadequate containment, segregation, and cleaning protocols for beta-lactam drug production, which posed a significant cross-contamination risk by processing these drugs in the same ISO 5 hood as non-beta-lactams without proper surface cleaning between batches. Furthermore, the facility did not routinely use sporicidal agents in its critical ISO 5 aseptic processing areas. Personnel exhibited several deficiencies in aseptic technique, such as exposed hands, wrists, and facial hair within the ISO 5 area during sterile operations and gowning. There were also instances of gloved hands contacting non-aseptic surfaces without subsequent sanitization or replacement before resuming aseptic tasks, and unsanitized materials were introduced into the controlled environment. These observations necessitate that PharmScript, LLC implement comprehensive corrective and preventive actions to enhance sterile manufacturing practices and ensure drug product quality and patient safety.