Drug factory · FDA FEI 3002957541
Sun Pharmaceutical Industries Limited (formerly known as Sun Pharmaceutical Medicare Limited)
Survey No. 22 and 24 - Village :- Ujeti Post - Baska, Halol Panchmahal, India
No problems found at FDA's last inspection, Feb 27, 2024.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2017: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 27, 2024 | No problems found | Drug Quality Assurance | — |
| Jul 13, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Feb 5, 2019 | No problems found | Drug Quality Assurance | — |
| Jun 2, 2017 | No problems found | 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.
Jul 13, 2023 inspection
- Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
Registered with FDA for: analysis; api manufacture; manufacture.