Drug factory · FDA FEI 3010228235
Torrent Pharmaceuticals Limited
Plot No. Z/104 to 106, Dahej SEZ Part-II, Taluka Vagra, Dist. Bharuch, Bharuch, India
No problems found at FDA's last inspection, Jan 23, 2026.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2015: 2 with no problems, 2 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 23, 2026 | No problems found | Drug Quality Assurance | — |
| May 25, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Mar 19, 2019 | Serious problems, FDA action | Drug Quality Assurance | — |
| May 26, 2017 | No problems found | Drug Quality Assurance | — |
| Apr 10, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
May 25, 2023 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
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. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: analysis; api manufacture; manufacture; pack.