Company
United StatesStarkey Laboratories Inc, Eden Prairie, MN – FDA Inspections
Inspection records and compliance data for Starkey Laboratories Inc in Eden Prairie, Minnesota. 5 FDA inspections on record, 1 Form 483, last inspected June 26, 2025.
Company Profile
This profile covers Starkey Laboratories Inc based in Eden Prairie, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 0
- NAI
- 5
- Form 483s
- 1
- Warning letters
- 0
First inspected July 7, 2009. Last inspected June 26, 2025.
Most cited issue areas
- Procedures not adequately established or maintained1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 26, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1264301 |
| November 13, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1071531 |
| October 1, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 898175 |
| December 15, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 759329 |
| July 7, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 595817 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Starkey Laboratories Inc
FEI Number
2125608
Address
6700 Washington Ave S, Eden Prairie, Minnesota 55344, United States
Country
United States
ID: b547bdab-e144-4d52-b606-9e060b2758eb