Company
IrelandIntegra Lifesciences (Ireland) Limited, SRAGH Tullamore, Ireland – FDA Inspections
Inspection records and compliance data for Integra Lifesciences (Ireland) Limited in SRAGH Tullamore. 5 FDA inspections on record, 1 Form 483, last inspected December 14, 2018.
Company Profile
This profile covers Integra Lifesciences (Ireland) Limited based in SRAGH Tullamore, Ireland.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 30, 2010. Last inspected December 14, 2018.
Most cited issue areas
- Lack of or inadequate In-process acceptance procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Management review - Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 14, 2018 | Not classified | Medical Devices & Rad Health | 1094949 |
| April 26, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1072147 |
| March 5, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 919158 |
| August 23, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 799848 |
| September 30, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 694696 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Integra Lifesciences (Ireland) Limited
FEI Number
3006697299
Address
Tullamore Business & Technology Park, IDA BUSINESS and TECHNOLOGY PARK, SRAGH Tullamore, Ireland
Country
Ireland
ID: 9d1683e2-95a2-48b6-8943-295c852ba3ce