Inspection Record

Drug Depot, Inc. dba APS Pharmacy — FDA 483 Findings

US FDAInspected 2018-07-26Published 2024-01-17 3 findingsEquipment and facilityAseptic processing and sterility assuranceContamination control

View the regulator's official source The source document is always the basis for judgement.

Findings

1Equipment and facility

The ISO-classified area has difficult to clean, particle-generating, or visibJy dirty equipment or surfaces.

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.

Other records for this company

2016-03-07 · US FDA · 9 findings2022-06-17 · US FDA · 4 findings
Drug Depot, Inc. dba APS Pharmacy company profile — full history US FDA documents, 2024 Go to Findings search