1Aseptic processing and sterility assurance
Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area.
Inspection Record
Drug Depot, LLC., dba APS Pharmacy — FDA 483 Findings
Inspectors Saundrea A MunroeThe 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
Personnel conducted aseptic manipulations in an area that blocked the movement of first pass air aroun d an open unit, either before or after it was filled with sterile product.
3Aseptic processing and sterility assurance
Personnel moved rapidly in the vicinity of open sterile units and instruments, which disrupted th e airflow and increased the risk of bringing lesser quality air into the ISO 5 classified aseptic processin g area.
4Aseptic processing and sterility assurance
The ISO 5 classified aseptic processing areas had difficult to clean, particle-generating and visibly dirty equipment or smface.
About this record
Extracted automatically from the document US FDA published on 2022-11-07. 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.
