Company
United StatesGreatbatch Ltd, Beaverton, OR – FDA Inspections
Inspection records and compliance data for Greatbatch Ltd in Beaverton, Oregon. 4 FDA inspections on record, last inspected March 23, 2017.
Company Profile
This profile covers Greatbatch Ltd based in Beaverton, Oregon, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected January 13, 2010. Last inspected March 23, 2017.
Most cited issue areas
- Documentation1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 23, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1008017 |
| May 16, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 879257 |
| August 21, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 795448 |
| January 13, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 638223 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Greatbatch Ltd
FEI Number
3002755179
Address
9305 Sw Nimbus Ave, Beaverton, Oregon 97008, United States
Country
United States
ID: f120358b-088c-49cc-a0d3-722c3013d63c