FDA Inspection
Torrent Pharmaceuticals LimitedTorrent Pharmaceuticals Limited – FDA Inspection, Jun 15, 2018
Record Details
This FDA Inspection record concerns Torrent Pharmaceuticals Limited, with an inspection on June 15, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · fc876dbe-932e-49d4-9b1b-841a0c89aa10
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055697
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 314.80(c)(2)(ii)(B)Late submission of an ICSR
- 21 CFR 314.80(c)(2)(ii)(B)Periodic safety report missing ICSR
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Other FDA inspections of Torrent Pharmaceuticals Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 4, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 15, 2021 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 28, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 4, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for Torrent Pharmaceuticals Limited
- FDA Inspection 1256784 - 2024-10-04
- FDA Inspection 1161232 - 2021-12-15
- FDA Inspection 1051188 - 2018-02-28
- FDA Inspection 1038709 - 2017-12-04
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