1Equipment and facility
There is a lack of adequate separation within facility design and equipment placement within the ISO classified and non-classified areas to prevent contamination.
Inspection Record
Talon Compounding Pharmacy — FDA 483 Findings
Inspectors Camerson E MooreThe 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
Your facility design allowed the influx of poor quality air into a higher classified area.
3Aseptic processing and sterility assurance
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worse-case activities and conditions that provide a challenge to aseptic operations.
4Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed with exposed hair.
5Environmental monitoring
Cleanroom certification for your ISO classified areas are inadequate.
6Aseptic processing and sterility assurance
Equipment was not disinfected prior to entering the aseptic processing areas.
7Other quality system
There is a lack of adequate controls to prevent mix-ups.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
