Inspection Record

Central Admixture Pharmacy Services, Inc. — FDA 483 Findings

US FDAInspected 2016-02-10Published 2024-01-17 3 findingsAseptic processing and sterility assuranceTraining and personnel

Inspectors Sarah M 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

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

2Training and personnel

Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.

3Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.

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

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Central Admixture Pharmacy Services, Inc. findings history — including this company's other documents US FDA documents, 2024 Go to Findings search