1Aseptic processing and sterility assurance
The use of sporicidal agents in the ISO 5 classified aseptic processing area was inadequate.
Inspection Record
PharmScript, LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic 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.
3Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were obse1ved with exposed hands, exposed wrists and exposed hair.
4Contamination control
You produced beta-lactam drugs without providing adequate containment, segregation and cleaning of work surfaces to prevent cross-contamination.
About this record
Extracted automatically from the document US FDA published on 2019-10-21. 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.
