Inspection Record

RC Outsourcing LLC — FDA 483 Findings

US FDAInspected 2019-02-08Published 2020-07-09 6 findingsLaboratory and QC controlsMaterial and supplier controlDeviation, CAPA, and investigationAseptic processing and sterility assuranceStability and storage

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

Findings

1Laboratory and QC controls

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

2Material and supplier control

Specific identification tests are not conducted on components that have been accepted based on the suppliers report of analysis.

3Deviation, CAPA, and investigation

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

4Aseptic processing and sterility assurance

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

5Laboratory and QC controls

The accuracy, sensitivity and reproducibility of test methods have not been established and documented.

6Stability 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 2020-07-09. 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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