1Equipment and facility
Production areas have difficult to clean or contain porous, particle generating, or visibly duty equipment or surfaces.
Inspection Record
Lt Col Luke Weather Jr Veterans Affairs Medical Center — FDA 483 Findings
Inspectors Demario L WallsThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions.
3Aseptic processing and sterility assurance
Personnel were observed conducting aseptic manipulations where the movement of "first air" in the ISO 5 area is blocked or disrupted.
4Aseptic processing and sterility assurance
Smoke studies were inadequately performed under dynamic conditions.
5Training and personnel
Personnel were observed moving quickly in a critical area or in an area immediately adjacent to a critical area likely causing disruption of unidirectional airflow.
6Aseptic processing and sterility assurance
Personnel performed aseptic manipulations with exposed hair or skin.
7Material and supplier control
Materials were exposed to lower than ISO 5 quality air.
8Other quality system
Lack of disinfection of supplies at each transition from areas of lower quality air to areas of higher quality air.
9Equipment and facility
Failure to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO 5 area.
About this record
Extracted automatically from the document US FDA published on 2026-07-23. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
