Overton Brooks VA Medical Center – FDA 483, Feb 12, 2020

The FDA Form 483 documents observations from an inspection of a facility producing sterile hazardous and non-hazardous drug products. The facility utilizes ISO 5 classified aseptic processing areas, specifically a (b)(4) in the Hazardous Area (Room (b)(4)) and a (b)(4) in the Non-Hazardous Area (Room (b)(4)). Both ISO 5 classified areas are located within unclassified rooms.

A key observation was that the antechambers of these ISO 5 classified areas do not supply a continuous flow of HEPA filtered air. On February 3, 2020, a pharmacist was observed opening the (b)(4) ISO 5 classified antechamber, exposing its interior to unclassified air from the surrounding room during material transfer from the "segregated compounding area" (SCA). Additionally, the antechamber's interior surfaces were not disinfected prior to material movement. These (b)(4) and (b)(4) have been operational in their current locations since May 2017.

Another observation involved a portable air conditioner with a condenser water tank located approximately 97 inches from the (b)(4) (ISO 5 Classified) in the non-hazardous SCA (Room (b)(4)). This air conditioner, present from June 2017 to February 4, 2020, was deemed to be in close enough proximity to potentially compromise the air