FDA Inspection
Mts Europe GmbhMts Europe Gmbh – FDA Inspection, Feb 19, 2015
Record Details
This FDA Inspection record concerns Mts Europe Gmbh, with an inspection on February 19, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mts Europe Gmbh
- Inspection Date
- February 19, 2015
- Product Type
- Devices
View Company Profile
ID · 9a0e433a-b317-4561-a066-879a155a2c99
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 921243
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
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Other FDA inspections of Mts Europe Gmbh
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 2, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Mts Europe Gmbh
- FDA Inspection 595236 - 2009-07-02
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