1Equipment and facility
Vermin was observed in your production area.
Inspection Record
Westlab Pharmacy Inc. dba Westlab Pharmacy — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Environmental monitoring
I A water source is present in the cleanroom where the ISO 5 area is located.
3Aseptic processing and sterility assurance
Personnel were observed·conducting aseptic manipulations or placing equipment/supplies in an area that blocked the movement of first pass air around an open unit, whether before or after it is filled with sterile product.
4Material and supplier control
Non-pharmaceutical <Redacted B4> (not meeting specifications otf <Redacted B4> was used as a component within non-sterile drug production.
5Aseptic processing and sterility assurance
Environmental monitoring was not performed in your aseptic processing areas.
6Aseptic 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.
7Contamination control
Hazardous drugs wen: produced without providing adequate cleaning of work surfaces, utensils, and/or, personnel to prevent cross-contamination.
About this record
Extracted automatically from the document US FDA published on 2022-09-27. 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.
