Drug factory · FDA FEI 3012932394
Graviti Pharmaceuticals Private Limited
Survey No. 621/E & 621/EE, Isnapur Village, Patancheru Mandal, Sangareddy, India
Problems found, fixed voluntarily at FDA's last inspection, Jul 28, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2023: 1 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 |
|---|---|---|---|
| Jul 28, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Feb 3, 2023 | 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 28, 2026 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. - 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. - Component written specification 21 CFR 211.84(d)(2)
Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Registered with FDA for: analysis; manufacture.