1Contamination control
Personnel failed to disinfect or change gloves frequently enough to prevent contamination.
Inspection Record
Pharmacy Associates, 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
Disinfecting agents and cleaning pads or wipes used in the ISO 5 area [aseptic processing areas] are not sterile.
3Aseptic processing and sterility assurance
Personnel were observed to be moving rapidly in the vicinity of open sterile units or instruments which disrupted the airflow and increased the risk of bringing lesser quality air into the ISO 5 area.
4Aseptic processing and sterility assurance
Post filtration integrity testing to the sterilizing filter was not performed.
5Aseptic 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.
6Environmental monitoring
Sporicidal agents are not used in your facility's clean room and/or ISO 5 area.
7Training and personnel
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.
8Aseptic processing and sterility assurance
Environmental monitoring was not performed in your aseptic processing areas.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
