Company
United StatesbioMerieux, Inc., Durham, NC – FDA Inspections
Inspection records and compliance data for bioMerieux, Inc. in Durham, North Carolina. 4 FDA inspections on record (2 OAI), 1 Form 483, last inspected April 10, 2017.
Company Profile
This profile covers bioMerieux, Inc. based in Durham, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 2
- VAI
- 0
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected March 6, 2012. Last inspected April 10, 2017.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Supplier oversight1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 10, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1015629 |
| January 5, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 961531 |
| June 14, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 837677 |
| March 6, 2012 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 772522 |
FDA documents
People (6)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
bioMerieux, Inc.
FEI Number
3002769706
Address
100 Rodolphe St, Durham, North Carolina 27712, United States
Country
United States
ID: 0e90e065-1a28-4743-9958-555322a42a36