FDA Inspection
Dornier Medtech Systems GmbHDornier Medtech Systems GmbH – FDA Inspection, Apr 29, 2011
Record Details
This FDA Inspection record concerns Dornier Medtech Systems GmbH, with an inspection on April 29, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dornier Medtech Systems GmbH
- Inspection Date
- April 29, 2011
- Product Type
- Devices
View Company Profile
ID · fa64b0d1-39ab-4165-b4c1-678ece67fdb3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 726892
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Dornier Medtech Systems GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Dornier Medtech Systems GmbH
- FDA Inspection 1194137 - 2022-12-14
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.