FDA Inspection
Transcoject GmbHTranscoject GmbH – FDA Inspection, Feb 19, 2015
Record Details
This FDA Inspection record concerns Transcoject GmbH, with an inspection on February 19, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Transcoject GmbH
- Inspection Date
- February 19, 2015
- Product Type
- Devices
View Company Profile
ID · 9894c400-a62c-413f-9da4-9c6a037c1672
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 917902
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
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Other FDA inspections of Transcoject GmbH
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 2, 2025 | Not classified | Office of Inspections and Investigations | |
| April 2, 2025 | Not classified | Office of Inspections and Investigations | |
| March 9, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Transcoject GmbH
- FDA Inspection 1268427 - 2025-04-02
- FDA Inspection 1268375 - 2025-04-02
- FDA Inspection 1004177 - 2017-03-09
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