1Equipment and facility
Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces.
Inspection Record
Central Alabama Veterans Health Care System — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Use of non-sterile disinfecting agents in the ISO 5 area.
3Aseptic processing and sterility assurance
Smoke studies were inadequately performed under dynamic conditions.
4Equipment and facility
No measurement of room pressure differentials was observed during operations to demonstrate proper airflow.
5Equipment and facility
Failure to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO 5 area.
6Environmental monitoring
Inadequate routine environmental monitoring in the ISO 5 area.
7Other quality system
Lack of disinfection of supplies at each transition from areas of lower quality air to areas of higher quality air.
8Aseptic processing and sterility assurance
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions.
About this record
Extracted automatically from the document US FDA published on 2026-05-27. 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.
