Company
GermanyTutogen Medical GmbH, Neunkirchen a. Brand, Germany – FDA Inspections
Inspection records and compliance data for Tutogen Medical GmbH in Neunkirchen a. Brand. 7 FDA inspections on record, 1 Form 483, last inspected June 25, 2026.
Company Profile
This profile covers Tutogen Medical GmbH based in Neunkirchen a. Brand, Germany.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 0
- NAI
- 6
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 27, 2009. Last inspected June 25, 2026.
Most cited issue areas
- Environmental control Lack of or inadequate procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 25, 2026 | NAI | · Human Cellular, Tissue, and Gene Therapies | 1325500 |
| August 31, 2023 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1220073 |
| March 8, 2018 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1048872 |
| January 26, 2017 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1002596 |
| September 23, 2015 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 943795 |
| January 18, 2013 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 815199 |
| November 27, 2009 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 634593 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Tutogen Medical GmbH
FEI Number
3002924436
Address
Neunkirchen am Brand, Industriestr. 6, Neunkirchen a. Brand, Germany
Country
Germany
ID: c713e59b-31db-48dd-9c02-998fb9c1e235