Company
United StatesGreatbatch Medical, Plymouth, MN – FDA Inspections
Inspection records and compliance data for Greatbatch Medical in Plymouth, Minnesota. 8 FDA inspections on record, last inspected June 07, 2024.
Company Profile
This profile covers Greatbatch Medical based in Plymouth, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 1
- NAI
- 6
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 27, 2009. Last inspected June 7, 2024.
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 7, 2024 | Not classified | Medical Devices & Rad Health | 1236555 |
| May 23, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1054275 |
| May 25, 2016 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 974240 |
| May 6, 2015 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 926242 |
| March 18, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 870467 |
| June 20, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 838074 |
| June 27, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 777168 |
| February 27, 2009 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 572370 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Greatbatch Medical
FEI Number
2183787
Address
2300 Berkshire Ln N, Plymouth, Minnesota 55441, United States
Country
United States
ID: e1c44da3-5f7d-420d-ad9d-dcb9147ad19f