Overton Brooks VA Medical Center – FDA 483, Feb 17, 2017

The FDA Form 483 inspection revealed multiple deficiencies in the facility's aseptic processing and quality control systems. The cleaning and disinfection system for aseptic processing areas was found deficient, with housekeeping personnel entering ISO 7 areas during active aseptic operations. Visible discoloration (rust) was observed on a staging shelf near the LAFW (ISO 5 Hood) and on return air vents. Soiled HEPA filters were noted in the LAFW (ISO 5 Hood) in the IV Buffer room, reportedly not replaced since at least 2012.

Significant debris and residue build-up were observed in ISO 5 areas (LAFW, grate, light cover, HEPA bolts, (b)(4) used in (b)(4) process) and ISO 7 areas (supply shelf, light switch, (b)(4)). A thread-like material was found on equipment in the IV Chemo room. Lint-free cleaning cloths for ISO 5 areas were not sterile. A non-cleanroom suitable chair was observed in the IV chemo buffer room.

The firm continued sterile drug product production during facility construction without adequate contamination controls. In-house surface, air, and fingertip sampling using (b)(4) media failed to follow manufacturer recommendations for controlled incubation. Surface and air sampling were not performed in the (b)(4) (ISO 5) in 2016. Fingertip sampling was not conducted on approximately 27% of pharmacists