Company
SwitzerlandBioptron AG, Wollerau, Switzerland – FDA Inspections
Inspection records and compliance data for Bioptron AG in Wollerau. 1 FDA inspection on record, 1 Form 483, last inspected November 02, 2017.
Company Profile
This profile covers Bioptron AG based in Wollerau, Switzerland.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected November 2, 2017.
Most cited issue areas
- Description of function, op. characteristics, uses1 inspection
- Design input - documentation1 inspection
- Design review - Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 2, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1031661 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bioptron AG
FEI Number
3003775404
Address
Sihleggstrasse 23, Wollerau, Switzerland
Country
Switzerland
ID: 35b8f67d-a420-4f38-bbe4-32c75b23fc97