1Aseptic processing and sterility assurance
Materials or supplies were not disinfected prior to entering the aseptic processing areas.
Inspection Record
CMC Enterprise Pharmacy — FDA 483 Findings
Inspectors Adam R Cooke · Rachael L CookThe 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 engaged in aseptic processing were observed with exposed hair.
3Training and personnel
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.
4Equipment and facility
Your facility was designed and/or operated in a way that permits poor flow of personnel and materials.
5Aseptic processing and sterility assurance
The ISO 5 classified aseptic processing areas had difficult to clean, particle generating and visibly dirty equipment or surface.
6Aseptic processing and sterility assurance
You had inadequate HEPA filter airflow over the area to which sterile product was exposed.
7Equipment and facility
Your facility design allowed the influx of poor quality air into a higher classified area.
8Aseptic processing and sterility assurance
Media fills (aseptic process simulations) were not perfonned that closely simulate aseptic production operations incorporating, as approp1iate, worst-case activities, representative volume, and conditions that provide a challenge to aseptic operations.
About this record
Extracted automatically from the document US FDA published on 2025-02-19. 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.
