FDA Inspection
K2 Health Products LLCK2 Health Products LLC – FDA Inspection, Nov 15, 2022
Record Details
This FDA Inspection record concerns K2 Health Products LLC, with an inspection on November 15, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- K2 Health Products LLC
- Inspection Date
- November 15, 2022
- Product Type
- Devices
View Company Profile
ID · 83fb61b4-1b1b-422e-a786-a6c53de8325f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1190598
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of K2 Health Products LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 3, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 10, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for K2 Health Products LLC
- FDA Inspection 970183 - 2016-02-03
- FDA Inspection 785086 - 2012-05-10
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