Inspection Record

Central Admixture Pharmacy Services, Inc. — FDA 483 Findings

US FDAInspected 2015-07-11Published 2024-01-17 6 findingsQuality unit oversightEquipment and facilityOther quality systemMaterial and supplier control

Inspectors Larrv K. AustinThe inspectors who signed the published document.Inspector lookup

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

Findings

1Quality unit oversight

Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification as a condition for their approval and release.

2Equipment and facility

The operations relating to the processing of penicilli.n are not pe.rfonned facilities separate from used for other drug products for human use.

3Other quality system

Air-handling systems for the processing of penicillin are not completely separate from those for other drug products for human use.Air-handling systems for the processing of penicillin are not completely separate from those for other drug products for human use .

4Material and supplier control

Reports of analysis from component suppliers are accepted in lieu oftesting each component for con form ity wjtb all appropriate written specifications, without establishing the reliability of the supplier's analyses tlu·ough appropriate validation of the supplier's test results at appropriate intervals.

5Equipment and facility

Buildings used in tbe processing of a drug product are not maintained in a good state of repair.

6Equipment and facility

There is a lack of written procedures describing in sufficient detail the methods, equipment and materials to be used for sanitation .

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

2025-09-05 · US FDA · 4 findings2025-09-05 · US FDA · 7 findings2015-07-11 · US FDA · 6 findings2024-08-13 · US FDA · 29 findings2024-05-21 · US FDA · 17 findings2024-05-14 · US FDA · 4 findings
Central Admixture Pharmacy Services, Inc. findings history — including this company's other documents US FDA documents, 2024 Go to Findings search