FDA 483 - Boothwyn Pharmacy LLC - September 08, 2021

The FDA conducted an inspection of Boothwyn Pharmacy LLC from August 17 to September 8, 2021, identifying significant deviations from manufacturing standards. The observations, detailed in a Form FDA 483, highlighted critical deficiencies in aseptic processing, environmental control, and quality assurance. Key issues included pharmacy technicians blocking critical airflow during sterile drug production, risking contamination. The facility also failed to adequately contain, segregate, and clean equipment for hazardous drugs, leading to potential cross-contamination. Furthermore, essential materials and personnel's gloves were not consistently disinfected before entering aseptic areas, and sporicidal agents were used incorrectly, with insufficient contact times on critical surfaces. Inspectors also noted that ISO 5 classified areas contained difficult-to-clean or particle-generating equipment, compromising sterility. Personnel monitoring practices were flawed, providing unrepresentative data. Crucially, media fills, designed to validate aseptic processes, were not performed under challenging conditions, and airflow certifications lacked dynamic operational simulation. Finally, the quality of water used in non-sterile drug production was not confirmed. These observations require Boothwyn Pharmacy to implement comprehensive corrective actions to ensure drug product safety and quality.