Inspection Record

Central Admixture Pharmacy Services, Inc. — FDA 483 Findings

US FDAInspected 2015-07-10Published 2024-01-17 3 findingsAseptic processing and sterility assuranceEquipment and facilityDeviation, CAPA, and investigation

Inspectors Michele L. Forster · Jeffrey D. MengThe inspectors who signed the published document.Inspector lookup

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

Findings

1Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established, written, and followed.

2Equipment and facility

The operations relating to the processing ofpenicillin are not performed in facilities separate from those used for other drug p roducts for human use.

3Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

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.

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Central Admixture Pharmacy Services, Inc. company profile — full history US FDA documents, 2024 Go to Findings search