Inspection Record

Apex Pharmacy, LLC — FDA 483 Findings

US FDAInspected 2019-11-07Published 2020-01-07 3 findingsAseptic processing and sterility assuranceContamination controlMaterial and supplier control

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

Findings

1Aseptic processing and sterility assurance

Personnel engaged in aseptic processing were observed with exposed hands.

2Contamination control

Non-microbial contamination was observed in your production area.

3Material and supplier control

Non-pharmaceutical grade components are used in the formulation of non-sterile drug products.

About this record

Extracted automatically from the document US FDA published on 2020-01-07. 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.

Apex Pharmacy, LLC company profile — full history US FDA documents, 2020 Go to Findings search