1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions.
Inspection Record
Potter's House Apothecary, Inc. — 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 were observed to manually contact a product contact surface while conducting aseptic operations.
3Aseptic processing and sterility assurance
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate worst-case activities and conditions that provide a challenge to aseptic operations.
About this record
Extracted automatically from the document US FDA published on 2020-12-30. 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.
