1Aseptic processing and sterility assurance
An operator rested their arms on the work surface of the hood during aseptic production.
Inspection Record
VA San Diego Healthcare Systems — FDA 483 Findings
Inspectors Cecilia H. Kieu · Matthew R. ClabeauxThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces.
3Other quality system
Lack of disinfection of supplies at each transition from areas of lower quality air to areas of higher quality air.
4Aseptic processing and sterility assurance
Personnel were observed touching equipment or other surfaces located outside of the ISO 5 area with gloved hands and then proceeding with aseptic processing without changing or sanitizing gloves.
5Contamination control
Beta-lactam drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.
6Aseptic processing and sterility assurance
Personnel performed aseptic manipulations with exposed hair or skin.
7Contamination control
Contamination was observed in your production area.
8Material and supplier control
Materials were exposed to lower than ISO 5 quality air.
9Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed wearing non-sterile gloves.
10Training 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.
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.
