FDA Inspection
KR Medical Technologies, LLC.KR Medical Technologies, LLC. – FDA Inspection, Aug 3, 2018
Record Details
This FDA Inspection record concerns KR Medical Technologies, LLC., with an inspection on August 3, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fdef53d7-a3b7-4cd6-a14f-ab0e07a3f8d1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1060935
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of KR Medical Technologies, LLC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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