Company
SwitzerlandBiotronik, AG, Bulach, Switzerland – FDA Inspections
Inspection records and compliance data for Biotronik, AG in Bulach. 5 FDA inspections on record, 2 Form 483s, last inspected January 24, 2019.
Company Profile
This profile covers Biotronik, AG based in Bulach, Switzerland.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected January 24, 2013. Last inspected January 24, 2019.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Documentation1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 24, 2019 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1087258 |
| March 9, 2018 | Not classified | Medical Devices & Rad Health | 1089612 |
| March 17, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 967279 |
| September 24, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 947090 |
| January 24, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 818837 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Biotronik, AG
FEI Number
3002808050
Address
Ackerstrasse 6, Bulach, Switzerland
Country
Switzerland
ID: b17190ac-395d-4442-9297-12bd60fe1464