FDA 483 - PharmScript, LLC - October 24, 2016

An FDA inspection conducted at PharmScript, LLC from October 4-24, 2016, identified significant deficiencies in the firm's manufacturing processes for both sterile and non-sterile drug products. The observations, detailed in an FDA 483 document, highlighted critical failures in maintaining Current Good Manufacturing Practice (CGMP) standards. Key issues included a lack of adequate environmental controls within the ISO 5 sterile compounding area, such as an unlocked door allowing uncontrolled personnel movement and insufficient procedures for gowning and aseptic processing. The firm produced sterile drugs despite documented excursions in temperature, pressure, and humidity without proper investigation, questioning product integrity. Personnel exhibited improper gowning techniques, including using non-sterile gloves that did not overlap with gowns, and failed to follow correct handwashing and garbing procedures. Furthermore, the ISO 5 area's certification was found inadequate, lacking dynamic smoke studies, and multiple HEPA filters failed airflow testing without subsequent investigation into product impact. The company also neglected to perform media fills that accurately simulated aseptic operations, particularly for ophthalmic eye drop production. Cleaning and disinfection protocols were deficient, using non-sterile agents and wipes, and omitting sporicidal agents. Finally, non-sterile drug production lacked sufficient controls to prevent contamination. PharmScript, LLC is required to implement thorough corrective and preventive actions to address these systemic issues, ensuring compliance with CGMP regulations and the safety and quality of their drug products.