FDA Inspection
Biotronik, AGBiotronik, AG – FDA Inspection, Mar 17, 2016
Record Details
This FDA Inspection record concerns Biotronik, AG, with an inspection on March 17, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Biotronik, AG
- Inspection Date
- March 17, 2016
- Product Type
- Devices
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ID · c7cf23ee-302f-48be-b11f-fae3d3fcf525
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 967279
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Biotronik, AG
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2019 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| March 9, 2018 | Not classified | Office of Inspections and Investigations | |
| September 24, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 24, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biotronik, AG
- FDA Inspection 1087258 - 2019-01-24
- FDA Inspection 1089612 - 2018-03-09
- FDA Inspection 947090 - 2015-09-24
- FDA Inspection 818837 - 2013-01-24
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