Drug factory · FDA FEI 3009864318
Deva Holding Anonim Sirketi - Cerkezkoy 2 Uretim Tesisi Subesi
Cerkezkoy Organize Sanayi Bol, No:26 Karaagac Mahallesi Fatih Bulvari, Kapakli, Tekirdag, Turkey
No problems found at FDA's last inspection, Dec 12, 2023.
No Action Indicated: inspectors found no objectionable conditions.
8 drug inspections on record since 2019: 2 with no problems, 0 with problems fixed voluntarily, 2 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Lenalidomide | Makes it | Devatis, Inc. | 73043-038, 73043-039, 73043-040 +3 |
| Temozolomide | Makes it | Ascend Laboratories, LLC, CivicaScript LLC, Devatis, Inc. | 67877-537, 67877-538, 67877-539 +15 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 12, 2023 | No problems found | Bioresearch Monitoring | — |
| Dec 12, 2023 | No problems found | Bioresearch Monitoring | — |
| Sep 23, 2022 | No problems found | Drug Quality Assurance | — |
| Sep 23, 2022 | No problems found | Drug Quality Assurance | — |
| Feb 15, 2019 | Serious problems, FDA action | Drug Quality Assurance | — |
| Feb 15, 2019 | Serious problems, FDA action | Drug Quality Assurance | — |
| Jan 18, 2019 | Serious problems, FDA action | Bioresearch Monitoring | — |
| Jan 18, 2019 | Serious problems, FDA action | Bioresearch Monitoring | — |
Registered with FDA for: api manufacture; manufacture.