FDA Inspection
Trokamed GmbHTrokamed GmbH – FDA Inspection, Jun 27, 2013
Record Details
This FDA Inspection record concerns Trokamed GmbH, with an inspection on June 27, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Trokamed GmbH
- Inspection Date
- June 27, 2013
- Product Type
- Devices
View Company Profile
ID · 6852a879-a9a6-4b3e-a829-54ada15f5019
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 839516
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Trokamed GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2018 | Not classified | Office of Inspections and Investigations | |
| February 19, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Trokamed GmbH
- FDA Inspection 1105884 - 2018-11-15
- FDA Inspection 961048 - 2016-02-19
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.