FDA Inspection
Tontarra Medizintechnik GmbhTontarra Medizintechnik Gmbh – FDA Inspection, Mar 27, 2014
Record Details
This FDA Inspection record concerns Tontarra Medizintechnik Gmbh, with an inspection on March 27, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tontarra Medizintechnik Gmbh
- Inspection Date
- March 27, 2014
- Product Type
- Devices
View Company Profile
ID · c0d9df4c-fd41-437b-89cc-4bbb5637a582
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 873811
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Tontarra Medizintechnik Gmbh
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 6, 2018 | Not classified | Office of Inspections and Investigations | |
| June 9, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Tontarra Medizintechnik Gmbh
- FDA Inspection 1077626 - 2018-12-06
- FDA Inspection 976324 - 2016-06-09
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