Company
IrelandMerit Medical Ireland Ltd., Galway, Ireland – FDA Inspections
Inspection records and compliance data for Merit Medical Ireland Ltd. in Galway. 4 FDA inspections on record (1 OAI), 2 Form 483s, 1 warning letter, last inspected October 04, 2018.
Company Profile
This profile covers Merit Medical Ireland Ltd. based in Galway, Ireland.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 1
First inspected September 15, 2011. Last inspected October 4, 2018.
Most cited issue areas
- Design verification - output does not meet input requirement1 inspection
- Documentation1 inspection
- Lack of or inadequate final acceptance procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 4, 2018 | Not classified | Medical Devices & Rad Health | 1122377 |
| October 26, 2017 | Not classified | Medical Devices & Rad Health | 1043182 |
| September 5, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 804060 |
| September 15, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 748653 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Merit Medical Ireland Ltd.
FEI Number
3000335778
Address
Parkmore Industrial Estate, Parkmore Business Park West, Galway, Ireland
Country
Ireland
ID: 3e205d92-3659-40de-afcb-bc6475d0c7e7