Drug factory · FDA FEI 3014930305
Hibrow Healthcare Private Limited
Survey No 258, Thiruvandavar Village, Sirupinayur Panchayat Uthiramerur Taluk, Kanchipuram, India
Problems found, fixed voluntarily at FDA's last inspection, Jan 30, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2026: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Acetazolamide | Makes it, tests it, packages it and labels it | Eywa Pharma Inc | 71930-008, 71930-009 |
| Baclofen | Makes it, tests it, packages it and labels it | Eywa Pharma Inc | 71930-006, 71930-007, 71930-066 |
| Fludrocortisone | Makes it, tests it, packages it and labels it | Eywa Pharma Inc | 71930-088 |
| Hydrocortisone | Makes it, tests it, packages it and labels it | Eywa Pharma Inc | 71930-078, 71930-079, 71930-080 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 30, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jan 30, 2026 inspection
- Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established. - Test methods 21 CFR 211.165(e)
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established.
Registered with FDA for: analysis; label; manufacture; pack.