Inspection Record

Torrent Pharmaceuticals Limited — FDA 483 Findings

US FDAInspected 2017-04-28Published 2017-05-11 3 findingsOther quality systemQuality unit oversightLaboratory and QC controls

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

Findings

1Other quality system

There is a failure to thoroughly investigate discrepancies whether or not the batch has been distributed.

2Quality unit oversight

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

3Laboratory and QC controls

Laboratory equipment used for analytical testing was used outside ofthe calibrated range.

About this record

Extracted automatically from the document US FDA published on 2017-05-11. 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, 2017 Go to Findings search