Inspection Record

Torrent Pharmaceuticals Limited — FDA 483 Findings

US FDAInspected 2023-12-11Published 2023-12-28 5 findingsDeviation, CAPA, and investigationQuality unit oversightLaboratory and QC controlsEquipment and facilityMaterial and supplier control

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.

2Quality unit oversight

The responsibilities and procedures applicable to the quality unit are not in writing and fully followed for your formulation manufacturing operations.

3Laboratory and QC controls

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

4Equipment and facility

Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions, contamination, that would alter the safety, identity, strength, quality or purity of the drug product.

5Material and supplier control

Components for drug product manufacturing are not weighed and measured.

About this record

Extracted automatically from the document US FDA published on 2023-12-28. 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

2024-06-12 · US FDA · 3 findings2019-04-16 · US FDA · 4 findings2017-04-28 · US FDA · 3 findings
Torrent Pharmaceuticals Limited company profile — full history US FDA documents, 2023 Go to Findings search