Company
GermanyTranscoject GmbH, Neumunster, Germany – FDA Inspections
Inspection records and compliance data for Transcoject GmbH in Neumunster. 4 FDA inspections on record, 1 Form 483, last inspected April 02, 2025.
Company Profile
This profile covers Transcoject GmbH based in Neumunster, Germany.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected February 19, 2015. Last inspected April 2, 2025.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Lack of or inadequate procedures for storage.1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 2, 2025 | Not classified | Biologics | 1268427 |
| April 2, 2025 | Not classified | Medical Devices & Rad Health | 1268375 |
| March 9, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1004177 |
| February 19, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 917902 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Transcoject GmbH
FEI Number
3002655329
Address
Rugenstr. 8, Neumunster, Germany
Country
Germany
ID: 910de755-7091-4d47-b24b-65c3d9f3fd2d