FDA Inspection
Labone, LLC.Labone, LLC. – FDA Inspection, Nov 30, 2018
Record Details
This FDA Inspection record concerns Labone, LLC., with an inspection on November 30, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fbf7b117-94ad-485d-b13b-7e24dec431b1
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1073116
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Labone, LLC.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 15, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 25, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 22, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 14, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Labone, LLC.
- FDA Inspection 1287938 - 2025-10-15
- FDA Inspection 1195898 - 2023-01-25
- FDA Inspection 927425 - 2015-05-22
- FDA Inspection 680543 - 2010-09-14
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