FDA Inspection
Xhale Assurance, Inc.Xhale Assurance, Inc. – FDA Inspection, Apr 5, 2019
Record Details
This FDA Inspection record concerns Xhale Assurance, Inc., with an inspection on April 5, 2019, issued by the New England District Office, covering medical devices & rad health.
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ID · d557f334-49aa-4b33-a81f-88a7843402ea
Inspection Facts
- Inspection number
- 1085814
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Xhale Assurance, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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