Drug factory · FDA FEI 3008248967
Pharmazell (India) Private Limited
Plot No.115, Visakha Pharmacity Limited. SEZ, Parawada, Anakapalli, India
Problems found, fixed voluntarily at FDA's last inspection, Feb 7, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2011: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Guanfacine | Makes the active ingredient | Takeda Pharmaceuticals America, Inc. | 54092-513, 54092-515, 54092-517 +1 |
| Mesalamine | Makes the active ingredient | Takeda Pharmaceuticals America, Inc. | 54092-100, 54092-476 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 7, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 14, 2018 | No problems found | Drug Quality Assurance | — |
| Feb 6, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 1, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.