Drug factory · FDA FEI 3008966143
Deva Holding A S-Kartepe Uretim Tesisleri
DUMLUPINAR MAHALLESI, 2 ANKARA CADDESI, Kocaeli, Turkey
No problems found at FDA's last inspection, Dec 6, 2023.
No Action Indicated: inspectors found no objectionable conditions.
3 drug inspections on record since 2015: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amoxicillin and Clavulanic Acid | Makes it | Devatis, Inc. | 73043-008, 73043-009 |
| Arformoterol | Makes it | Devatis, Inc. | 73043-052 |
| Brimonidine and Timolol | Makes it | Devatis, Inc. | 73043-029 |
| Cyclosporine | Makes it | Devatis, Inc. | 73043-005 |
| Formoterol | Makes it | Devatis, Inc. | 73043-051 |
| Furosemide | Makes it | Devatis, Inc. | 73043-022, 73043-023, 73043-024 +2 |
| Isosulfan Blue Inner Salt | Makes it | Devatis, Inc. | 73043-093 |
| Levocarnitine | Makes it | Devatis, Inc. | 73043-034 |
| Pantoprazole | Makes it | Devatis, Inc. | 73043-020 |
| Succinylcholine | Makes it | Devatis, Inc., TruPharma LLC. | 73043-021, 52817-734 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 6, 2023 | No problems found | Bioresearch Monitoring | — |
| Jul 25, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 30, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: manufacture.