FDA Inspection
Xanacare Technologies, LLCXanacare Technologies, LLC – FDA Inspection, Jul 17, 2009
Record Details
This FDA Inspection record concerns Xanacare Technologies, LLC, with an inspection on July 17, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Xanacare Technologies, LLC
- Inspection Date
- July 17, 2009
- Product Type
- Devices
View Company Profile
ID · 9fa279fd-b96e-4bf8-aa0b-47cadb862248
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 595244
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 820.198(a)General
- 21 CFR 820.20Management responsibility
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Xanacare Technologies, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 23, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 4, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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