FDA Inspection
Dornier Medtech America, Inc.Dornier Medtech America, Inc. – FDA Inspection, Mar 5, 2010
Record Details
This FDA Inspection record concerns Dornier Medtech America, Inc., with an inspection on March 5, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 5, 2010
- Product Type
- Devices
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ID · b7dc3882-df93-4fe0-819d-b74438a1438a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 653108
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(b)Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Dornier Medtech America, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 24, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 31, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Dornier Medtech America, Inc.
- FDA Inspection 1028402 - 2017-08-24
- FDA Inspection 842224 - 2013-05-31
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