Company
United StatesLabone, LLC., Lenexa, KS – FDA Inspections
Inspection records and compliance data for Labone, LLC. in Lenexa, Kansas. 5 FDA inspections on record, 1 Form 483, last inspected October 15, 2025.
Company Profile
This profile covers Labone, LLC. based in Lenexa, Kansas, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 0
- NAI
- 5
- Form 483s
- 1
- Warning letters
- 0
First inspected September 14, 2010. Last inspected October 15, 2025.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 15, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1287938 |
| January 25, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1195898 |
| November 30, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1073116 |
| May 22, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 927425 |
| September 14, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 680543 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Labone, LLC.
FEI Number
1930987
Address
10101 Renner Blvd, Lenexa, Kansas 66219, United States
Country
United States
ID: bbd9476d-d7df-45d7-a911-0bdc05684dc4