FDA Inspection
Tontarra Medizintechnik GmbhTontarra Medizintechnik Gmbh – FDA Inspection, Jun 9, 2016
Record Details
This FDA Inspection record concerns Tontarra Medizintechnik Gmbh, with an inspection on June 9, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tontarra Medizintechnik Gmbh
- Inspection Date
- June 9, 2016
- Product Type
- Devices
View Company Profile
ID · 6ea746a4-2aad-4767-8ea6-90488d08fc97
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 976324
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Tontarra Medizintechnik Gmbh
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 6, 2018 | Not classified | Office of Inspections and Investigations | |
| March 27, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Tontarra Medizintechnik Gmbh
- FDA Inspection 1077626 - 2018-12-06
- FDA Inspection 873811 - 2014-03-27
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