Drug factory · FDA FEI 3003510514
Hetero Drugs Limited
Unit I, Sy. No. 213, 214 & 255, Bonthapally Village, Gummadidala Mandal, , Sangareddy district, India
Problems found, fixed voluntarily at FDA's last inspection, May 16, 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 2010: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Tetrabenazine | Makes the active ingredient | Bionpharma Inc. | 69452-117, 69452-118 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 16, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 14, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 2, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 25, 2016 | No problems found | Drug Quality Assurance | — |
| May 2, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 11, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.