Drug factory · FDA FEI 3004149463
Divi's Laboratories Limited
Unit-2, Chippada Village, Annavaram Post Bheemunipatnam Mandal, Visakhapatnam District, India
Problems found, fixed voluntarily at FDA's last inspection, Jul 19, 2024.
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 2009: 2 with no problems, 5 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bosentan | Makes the active ingredient and tests it | Actelion Pharmaceuticals US, Inc. | 66215-101, 66215-102 |
| Naproxen and Sumatriptan | Makes the active ingredient | Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven | 42847-850 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 19, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 31, 2020 | No problems found | Drug Quality Assurance | — |
| Sep 19, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 6, 2016 | Serious problems, FDA action | Drug Quality Assurance | — |
| Feb 19, 2016 | No problems found | Drug Quality Assurance | — |
| Jun 6, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 19, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 9, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.