Drug factory · FDA FEI 3005658262
Analytical Solutions
B--22, MIDC, TTC Ind. Area, Navi Mumbai, India
Problems found, fixed voluntarily at FDA's last inspection, Nov 28, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2012: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Tranexamic Acid | Tests it | Provepharm Inc. | 81284-611, 81284-612 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 28, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Sep 12, 2025 | No problems found | Bioresearch Monitoring | — |
| Dec 15, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 23, 2018 | No problems found | Bioresearch Monitoring | — |
| May 20, 2015 | No problems found | Drug Quality Assurance | — |
| Sep 15, 2012 | 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.
Nov 28, 2025 inspection
- Acceptance of drug products 21 CFR 211.160(b)(3)
Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products. - 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. - Authority lacking to review records, investigate errors 21 CFR 211.22(a)
The quality control unit lacks authority to fully investigate errors that have occurred.
Registered with FDA for: analysis.