1Training 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.
Inspection Record
Richmond VA Medical Center — FDA 483 Findings
Inspectors Tekalign Wondimu · Michael O IdowuThe 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
Personnel performed aseptic manipulations with exposed hair or skin.
3Equipment and facility
Lack of disinfection of equipment at each transition from areas of lower quality air to areas of higher quality air.
4Equipment and facility
Failure to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO 5 area.
5Aseptic processing and sterility assurance
Smoke studies were not performed under dynamic conditions.
6Aseptic 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.
7Equipment and facility
Use of a sporicidal agent in the facility's ISO 5 areas was improper.
8Other quality system
Use of a disinfectant in a manner insufficient to achieve adequate levels of disinfection.
About this record
Extracted automatically from the document US FDA published on 2026-07-06. 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.
