1Equipment and facility
The ISO-classified area has difficult to clean, particle-generating, or visibJy dirty equipment or surfaces.
Inspection Record
Drug Depot, Inc. dba APS Pharmacy — 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 conducting aseptic manipulations that blocked the movement of first pass air around an open unit, whether before or after it is filled with sterile product.
3Contamination control
Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.
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.
