Inspection Record

Torrent Pharmaceuticals Limited — FDA 483 Findings

US FDAInspected 2024-06-12Published 2024-06-26 3 findingsDeviation, CAPA, and investigationEquipment and facilityStability and storage

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

Findings

1Deviation, CAPA, and investigation

(Repeat Observation from September 2022) rfhere is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any of its k:\omponents to meet any of its specifications whether or not the batch has been already distributed.

2Equipment and facility

(Repeat Observation from Sep ternber 2022) Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that ould alter the safety, identity, strength, quality or purity of the drug product.

3Stability and storage

There is no testing program designed to assess the stability characteristic of drug products.

About this record

Extracted automatically from the document US FDA published on 2024-06-26. 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

2023-12-11 · US FDA · 5 findings2019-04-16 · US FDA · 4 findings2017-04-28 · US FDA · 3 findings
Torrent Pharmaceuticals Limited company profile — full history US FDA documents, 2024 Go to Findings search