FDA Inspection
Tutogen Medical GmbHTutogen Medical GmbH – FDA Inspection, Jan 26, 2017
Record Details
This FDA Inspection record concerns Tutogen Medical GmbH, with an inspection on January 26, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · bd475a46-5628-4e56-8d94-40bc5e6fd0e9
Inspection Facts
- Inspection number
- 1002596
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of Tutogen Medical GmbH
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 25, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 31, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 8, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 23, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 18, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Tutogen Medical GmbH
- FDA Inspection 1325500 - 2026-06-25
- FDA Inspection 1220073 - 2023-08-31
- FDA Inspection 1048872 - 2018-03-08
- FDA Inspection 943795 - 2015-09-23
- FDA Inspection 815199 - 2013-01-18
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