Aizant Drug Research Solutions
Quick Facts: Aizant Drug Research Solutions
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- India
- Website
- https://www.aizant.com/
- Modalities
- Oral Solid Dose, Semi-solids & Liquids
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Aizant Drug Research Solutions
Aizant Drug Research Solutions is a contract development and manufacturing organization (CDMO). Capabilities: Oral Solid Dose, Semi-solids & Liquids. 1 manufacturing site registered with the U.S. FDA and Health Canada. Website: https://www.aizant.com/
Signal Score
Aizant Drug Research Solutions FDA Inspection History
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-07-31 |
Aizant Drug Research Solutions Private Ltd.
Hyderabad
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-11-14 |
Aizant Drug Research Solutions Private Ltd.
Hyderabad
Company-level
|
Bioresearch Monitoring | No | Voluntary Action Indicated (VAI) |
| 2023-04-28 |
Aizant Drug Research Solutions Private Ltd.
Hyderabad
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2023-01-25 |
Aizant Drug Research Solutions Private Ltd.
Hyderabad
Company-level
|
Bioresearch Monitoring | No | No Action Indicated (NAI) |
Aizant Drug Research Solutions FDA 483 Findings 3 observations · 2026-07-31 → 2026-07-31 ?
By subsystem
By severity
- 3 — Moderate: 1
- 2 — Minor: 2
- Repeat observations: 0
Most severe findings
-
Identity Testing of Each Component
"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."
-
Buildings not maintained in good state of repair
"Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair."
-
Cleaning SOPs/schedules
"Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules."