FDA 483 - Drug Crafters, L.P. - July 11, 2018

This FDA Form 483 document details observations made during an inspection concerning aseptic processing at an unnamed facility. The inspection, dated July 2, 2018, identified two key violations related to personnel practices during the production of sterile drug products.

The first observation notes that personnel engaged in aseptic processing failed to follow proper aseptic techniques. Specifically, a pharmacy technician was observed resting her elbows on the front of laminar airflow hood #1, an ISO 5 environment, while producing Vitamin C PF 500mg/mL, 30mL volume, Lot #06282018@37, with a Beyond Use Date of November 30, 2018.

The second observation indicates that personnel engaged in aseptic processing were observed with exposed skin. The same pharmacy technician, while producing the aforementioned sterile drug product in laminar airflow hood #1 (ISO 5 environment), had exposed skin surrounding her personal eyeglasses, and her sterile gowning did not overlap. These findings highlight deficiencies in aseptic technique and gowning procedures, which are critical for maintaining sterility in drug manufacturing.