1Aseptic processing and sterility assurance
The classified aseptic processing areas had difficult to clean and/or visibly dirty equipment or surface.
Inspection Record
The Compounding Pharmacy — FDA 483 Findings
Inspectors Adam R. CookeThe 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 poorer quality air into a higher classified area.
3Aseptic processing and sterility assurance
Non-depyrogenated equipment was used in sterile drug production.
About this record
Extracted automatically from the document US FDA published on 2022-03-14. 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.
