Infuscience FDA-483 Released

FDA has released the FDA-483 issued following a 4/17-4/25 inspection at Infuscience, an Eagan, MN, producer of sterile drug products. Inspection observations shown on the form were: 

•          visibly dirty equipment or surface in the ISO 5 classified aseptic processing area;
• ·        personnel moved rapidly in the vicinity of instruments, which disrupted the airflow and increased the risk of bringing lesser quality air into the ISO 5 classified aseptic processing area;
•          personnel conducted aseptic manipulations and placed equipment/supplies in an area that blocked the movement of first pass air around an open unit, either before or after it was filled with sterile product;
•          materials or supplies were not disinfected prior to entering the aseptic processing areas;
•          personnel engaged in aspetic processing were observed with exposed hands; and
•          ISO 5 classified areas were not certified under representative dynamic conditions.