Overton Brooks VA Medical Center — FDA 483 Findings

Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.

Th e system for monitoring and maintaining environmental conditions in the aseptic processing areas was deficient.

Equipment, materials, and/or supplies are not disinfected prior to entering the aseptic processing areas.

Personnel were observed conducting aseptic manipulations or placing equipment/supplies in an area that blocked the movement of first pass air around an open unit, whether before or after it is filled with sterile product.

There is inadequate HEPA filter coverage or airflow over the area to which sterile product is exposed.

The system for cleaning and disinfecting the aseptic processing areas are deficient.

1Y our firm continued producing sterile drug products while construction was ongoing within your facility without establishing adequate controls to prevent contamination of the production environment.

Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.

Your firm did not conduct smoke studies of the aseptic processing area under dynamic conditions.

Personnel were observed touching equipment or other surfaces located outside of the ISO 5 area with glovedhands and then proceeding with aseptic processing without changing or sanitizing gloves .