FDA Inspection
Biotronik, AGBiotronik, AG – FDA Inspection, Jan 24, 2013
Record Details
This FDA Inspection record concerns Biotronik, AG, with an inspection on January 24, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Biotronik, AG
- Inspection Date
- January 24, 2013
- Product Type
- Devices
View Company Profile
ID · 83a27c10-33d8-4817-9870-e9a58bc919cc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 818837
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.75(a)Documentation
Full citation text and observation details available on the Dashboard.
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 | |
| 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 |
Other documents for Biotronik, AG
- FDA Inspection 1087258 - 2019-01-24
- FDA Inspection 1089612 - 2018-03-09
- FDA Inspection 967279 - 2016-03-17
- FDA Inspection 947090 - 2015-09-24
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