1Environmental monitoring
Inadequate routine environmental monitoring in the ISO 5 area and classified areas.
Inspection Record
Jubilant DraxImage Radiopharmacies Inc. — FDA 483 Findings
Inspectors Jessica P Mcalister · 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
Personnel were observed performing aseptic processing outside of an ISO 5 area.
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.
4Aseptic processing and sterility assurance
Smoke studies were inadequately performed under dynamic conditions.
5Aseptic processing and sterility assurance
Personnel were observed conducting aseptic manipulations where the movement of 11first air" in the ISO 5 area is blocked or dismpted.
About this record
Extracted automatically from the document US FDA published on 2024-06-13. 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.
