Inspection Record

Claremore Compounding Center, Inc. — FDA 483 Findings

US FDAInspected 2020-01-24Published 2020-02-24 3 findingsMaterial and supplier controlLaboratory and QC controlsStability and storage

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

Findings

1Material and supplier control

You used a non-pharmaceutical grade component in the formulation of a drug product.

2Laboratory and QC controls

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.

3Stability and storage

There is no written testing program designed to assess the stability characteristics of drug products.

About this record

Extracted automatically from the document US FDA published on 2020-02-24. 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.

Claremore Compounding Center, Inc. company profile — full history US FDA documents, 2020 Go to Findings search