1Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed with exposed hair.
Inspection Record
Optum Infusion 483 Issued 03/18/2022 — FDA 483 Findings
Inspectors Truong X NguyenThe 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
The ISO 5 classified aseptic processing areas had particle-generating equipment or surface.
3Aseptic processing and sterility assurance
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was found to be present in the ISO 5 classified aseptic processing area during aseptic production.
4Aseptic processing and sterility assurance
Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area with gloved hands and then engaged in aseptic processing without changing or sanitizing gloves.
5Other quality system
Vennin was observed in your production area.
6Aseptic processing and sterility assurance
You had inadequate HEPA filter airflow over the area to which sterile product was exposed.
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.
