1Environmental monitoring
The scheduled use o hole room surface disinfection system disinfection system is <Redacted B4> rather than when spore forming organisms are identified through environmental monitoring.
Inspection Record
West Coast Nuclear Pharmacy, LLC — FDA 483 Findings
Inspectors Joanne E. King · Christos G. TsingelisThe 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
Disinfecting agents and cleaning pads or wipes used in the ISO 5 area [aseptic processing areas] are not sterile.
3Aseptic 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.
4Equipment and facility
The facility design was observed to allow the influx of poor quality air into a higher classified area.
5Aseptic processing and sterility assurance
Post <Redacted B4> testing to the sterilizing <Redacted B4> was not performed.
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.
