Inspection Record

Glenmark Pharmaceuticals Ltd. — FDA 483 Findings

US FDAInspected 2018-05-24Published 2018-06-05 4 findingsLaboratory and QC controlsDeviation, CAPA, and investigationQuality unit oversight

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

Findings

1Laboratory and QC controls

Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that conform to appropriate standards of identity, strength, quality and purity.

2Deviation, CAPA, and investigation

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

3Quality unit oversight

The responsibilities and procedures applicable to the quality control unit are not fully followed.

4Laboratory and QC controls

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

About this record

Extracted automatically from the document US FDA published on 2018-06-05. 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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Glenmark Pharmaceuticals Ltd. findings history — including this company's other documents US FDA documents, 2018 Go to Findings search