Drug factory · FDA FEI 3008243902
Aizant Drug Research Solutions PVT Ltd
Survey No 172 & 173, Apparel Park Road, Dulapally Village, Dundigal-Gandimaisamma Mandal, Medchal-Malkhajgiri District, Hyderabad, India
Problems found, fixed voluntarily at FDA's last inspection, Jul 31, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2018: 4 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 31, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Nov 14, 2025 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Apr 28, 2023 | No problems found | Drug Quality Assurance | — |
| Jan 25, 2023 | No problems found | Bioresearch Monitoring | — |
| Jan 24, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 3, 2019 | No problems found | Bioresearch Monitoring | — |
| Mar 15, 2019 | No problems found | Bioresearch Monitoring | — |
| Jul 13, 2018 | 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.
Jul 31, 2026 inspection
- Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair. - Cleaning SOPs/schedules 21 CFR 211.67(b)(2)
Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules. - Identity Testing of Each Component 21 CFR 211.84(d)(1)
The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
Registered with FDA for: analysis; manufacture; pack.