Drug factory · FDA FEI 3011171511
Dr. Reddy's Laboratories Limited
FTO-SEZ - Process-Unit - 02, Survey No. 70, 71 & 73, Devunipalavalasa (V), Ranasthalam Mandal, , , Srikakulam, India
Problems found, fixed voluntarily at FDA's last inspection, May 12, 2023.
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 2023: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Colchicine | Makes it and tests it | Dr. Reddy's Laboratories Inc. | 43598-372 |
| Isotretinoin | Makes it, tests it and packages it | BluePoint Laboratories., Dr.Reddy's Laboratories Ltd., JG Pharma Inc. | 68001-652, 68001-653, 68001-654 +9 |
| Nintedanib | Makes it and tests it | Dr. Reddy's Laboratories Inc. | 43598-147, 43598-148 |
| Prednisone | Makes it, tests it and packages it | Dr. Reddy's Laboratories Inc. | 43598-886, 43598-887, 43598-888 |
| Varenicline | Makes it, tests it and packages it | Dr. Reddy's Laboratories Inc. | 43598-022, 43598-023, 43598-907 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 12, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture; pack.