1Validation and qualification
IS0-5 classified areas were not certified under dynamic conditions.
Inspection Record
Sentara — FDA 483 Findings
Inspectors Sena G Dissmeyer · Brandy N Lepage · Karen A BriggsThe 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
The ISO 5 classified aseptic processing areas had difficult to clean and visibly dirty equipment or surface.
3Contamination control
You produced beta-lactam drugs without providing adequate cleaning of work surfaces to prevent cross-contamination.
4Aseptic processing and sterility assurance
Materials or supplies were not disinfected prior to entering the aseptic processing areas.
5Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed with exposed wlists and exposed hair.
6Aseptic processing and sterility assurance
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.
7Aseptic processing and sterility assurance
Personnel conducted aseptic manipulations and placed equipment/supplies in an area that blocked the movement of first pass air around an open unit, either before or after it was filled with sterile product.
8Aseptic processing and sterility assurance
Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area with gloved hands and then engaged in aseptic processing without changing or sanitizing gloves.
9Aseptic processing and sterility assurance
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.
About this record
Extracted automatically from the document US FDA published on 2023-07-19. 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.
