1Training and personnel
Personnel were observed putting on gowning apparel in a way that may cause the gowning apparel to become contaminated.
Inspection Record
Mandell’s Clinical Pharmacy — FDA 483 Findings
Inspectors Daniel J MinThe 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
Media fills were not performed that closely simulate aseptic production operations incorporating, as approp1iate, worst-case activities and conditions that provide a challenge to aseptic operations.
3Aseptic processing and sterility assurance
No assurance that sterile drug products were processed and stored under ISO 5 quality ai r.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do n ot include adequate validation of the sterilization process.
About this record
Extracted automatically from the document US FDA published on 2022-11-07. 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.
