Company
GermanyPublic company, NYSE: BIOBio-Rad Laboratories GmbH (NYSE: BIO), Munich, Germany – FDA Inspections
Inspection records and compliance data for Bio-Rad Laboratories GmbH in Munich. 2 FDA inspections on record (1 OAI), 1 warning letter, last inspected April 14, 2016. Publicly traded as NYSE: BIO.
Company Profile
This profile covers Bio-Rad Laboratories GmbH based in Munich, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 1
First inspected January 22, 2015. Last inspected April 14, 2016.
Most cited issue areas
- Design input - Lack of or inadequate procedures1 inspection
- Design review - Lack of or inadequate procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 14, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 971978 |
| January 22, 2015 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 915466 |
FDA documents
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Bio-Rad Laboratories GmbH
Stock ticker
BIO
Exchange
NYSE
Share price
$370.47
Market cap
$10.0B
Price as of
November 13, 2026
FEI Number
3001588913
Address
Heidemannstr. 164, Munich, Germany
Country
Germany
ID: b3b15860-d961-450a-a01c-04f0c1a4f400