1Aseptic processing and sterility assurance
Pressure differentials between areas with different air classifications were not monitored prior or during sterile drug production.
Inspection Record
Surgery Pharmacy Services, 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 engaged in aseptic processing were observed with exposed skin in critical areas.
3Equipment and facility
The ISO-classified equipment have difficult-to-clean, particle-generating, or visibly dirty equipment or surfaces.
4Aseptic processing and sterility assurance
Equipment, materials, and/or supplies are not disinfected prior to entering aseptic processing areas.
5Aseptic processing and sterility assurance
Disinfecting agents used in the ISO 5 area are not sterile.
6Validation and qualification
ISO-5 classified areas were not certified under dynamic conditions.
7Aseptic 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.
8Aseptic processing and sterility assurance
Actionable microbial contamination was present in the ISO 5 area or in adjacent areas during aseptic production without adequate product evaluation and remedial action.
9Contamination control
Personnel failed to disinfect or change gloves frequently enough to prevent contamination.
About this record
Extracted automatically from the document US FDA published on 2021-01-29. 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.
