Inspection Record

US Compounding Inc. — FDA 483 Findings

US FDAInspected 2016-08-22Published 2024-01-17 5 findingsQuality unit oversightAseptic processing and sterility assuranceDeviation, CAPA, and investigationEquipment and facility

Inspectors Massoud Motamed · Scott T. BallardThe 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

The quality control unit lacks the responsibility and authority to reject all drug products .

2Aseptic processing and sterility assurance

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

3Deviation, CAPA, and investigation

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

4Equipment and facility

Buildings used in the manufacture, processing.

5Aseptic processing and sterility assurance

Aseptic processing areas are defi cient regarding air supply tha t is filtered throu gh h ig h- effic ie nc y part ic ul at e ai r fi lte rs u nder positive pressure.

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

2016-09-01 · US FDA · 10 findings2017-09-14 · US FDA · 8 findings2019-02-07 · US FDA · 10 findings
US Compounding Inc. findings history — including this company's other documents US FDA documents, 2024 Go to Findings search