FDA Inspection
Xhale Assurance, Inc.Xhale Assurance, Inc. – FDA Inspection, Nov 21, 2013
Record Details
This FDA Inspection record concerns Xhale Assurance, Inc., with an inspection on November 21, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Xhale Assurance, Inc.
- Inspection Date
- November 21, 2013
- Product Type
- Devices
View Company Profile
ID · 853f1859-ec4d-4561-a719-d2cad7dcd6a3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 857325
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
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Other FDA inspections of Xhale Assurance, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2019 | Not classified | New England District Office | Compliance: Devices |
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