Inspection Record

Torrent Pharmaceuticals Limited — FDA 483 Findings

US FDAInspected 2019-04-16Published 2019-05-02 4 findingsDeviation, CAPA, and investigationProcess validationEquipment and facility

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

Findings

1Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already : distributed.

2Deviation, CAPA, and investigation

Out of Specification Investigation for API products is deficient.

3Process validation

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

4Equipment and facility

Routine calibration of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.

About this record

Extracted automatically from the document US FDA published on 2019-05-02. 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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Torrent Pharmaceuticals Limited company profile — full history US FDA documents, 2019 Go to Findings search