Company
United StatesGreiner Bio-One North America, Inc., Monroe, NC – FDA Inspections
Inspection records and compliance data for Greiner Bio-One North America, Inc. in Monroe, North Carolina. 7 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected September 14, 2023.
Company Profile
This profile covers Greiner Bio-One North America, Inc. based in Monroe, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 1
- VAI
- 2
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 1
First inspected January 15, 2010. Last inspected September 14, 2023.
Most cited issue areas
- Documentation of validated process performance2 inspections
- Design verification - output does not meet input requirement1 inspection
- DHR content1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 14, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1222303 |
| October 29, 2021 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1155664 |
| December 13, 2019 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1114241 |
| August 17, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1021970 |
| July 24, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 843981 |
| December 7, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 703137 |
| January 15, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 652912 |
FDA documents
Warning Letters (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Greiner Bio-One North America, Inc.
FEI Number
3001451379
Address
4238 Capital Dr, Monroe, North Carolina 28110, United States
Country
United States
ID: 5aa9ea16-ad85-4f85-9b30-efc0ae9b36de