FDA Inspection
Biotronik, AGBiotronik, AG – FDA Inspection, Mar 9, 2018
Record Details
This FDA Inspection record concerns Biotronik, AG, with an inspection on March 9, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Biotronik, AG
- Inspection Date
- March 9, 2018
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · f1eb24d7-12b8-46aa-a268-fa810095cee7
Inspection Facts
- Inspection number
- 1089612
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
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 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 1087258 - 2019-01-24
- FDA Inspection 967279 - 2016-03-17
- FDA Inspection 947090 - 2015-09-24
- FDA Inspection 818837 - 2013-01-24
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