FDA Inspection
Biotronik, AGBiotronik, AG – FDA Inspection, Jan 24, 2019
Record Details
This FDA Inspection record concerns Biotronik, AG, with an inspection on January 24, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · baf0e612-65e4-4e7b-b338-2b37de30d1ef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087258
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
Other FDA inspections of Biotronik, AG
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 9, 2018 | Not classified | Office of Inspections and Investigations | |
| March 17, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 1089612 - 2018-03-09
- FDA Inspection 967279 - 2016-03-17
- FDA Inspection 947090 - 2015-09-24
- FDA Inspection 818837 - 2013-01-24
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