1Equipment and facility
Your facility is designed and operated in a way that may permit the influx of lesser quality air into a higher quality air area.
Inspection Record
Surgery Pharmacy Services Inc — FDA 483 Findings
Inspectors Jared P StevensThe 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
Smoke studies were inadequately performed under dynamic conditions.
3Aseptic processing and sterility assurance
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions.
About this record
Extracted automatically from the document US FDA published on 2023-10-12. 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.
