Drug factory · FDA FEI 3005029956
Torrent Pharmaceuticals Limited
Ahmedabad-Mehsana Highway, Indrad, Taluka-Kadi, Dist. Mehsana, Indrad, India
Problems found, fixed voluntarily at FDA's last inspection, Jun 12, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2013: 0 with no problems, 5 with problems fixed voluntarily, 2 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 12, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 28, 2022 | Serious problems, FDA action | Drug Quality Assurance | 3 |
| Apr 16, 2019 | Serious problems, FDA action | Drug Quality Assurance | — |
| Apr 28, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 20, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 31, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 26, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 28, 2022 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. - Written record of complaint to include findings, follow-up 21 CFR 211.198(b)(2)
Written records of investigation of a drug complaint do not include the findings of the investigation and the follow-up. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Jul 26, 2013 inspection
- Test methods 21 CFR 211.165(e)
The specificity of test methods have not been established and documented.
Registered with FDA for: analysis; api manufacture; manufacture; pack.