1Contamination control
Non-microbial contamination was observed in your production area.
Inspection Record
Anderson Compounding Pharmacy, Inc. dba Anderson Compounding Pharmacy — FDA 483 Findings
Inspectors Xiaohui ShenThe 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 hazardous drugs without providing adequate containment to prevent cross-contamination.
4Other quality system
Unsealed, loose ceiling tiles were observed in your cleamoom.
About this record
Extracted automatically from the document US FDA published on 2019-09-16. 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.
