FDA Inspection
XENEX Disinfection Services Inc.XENEX Disinfection Services Inc. – FDA Inspection, Nov 20, 2019
Record Details
This FDA Inspection record concerns XENEX Disinfection Services Inc., with an inspection on November 20, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 20, 2019
- Product Type
- Devices
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ID · 1fb2fc34-43e2-4685-a1dd-91b17e7986e6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1110484
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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Other FDA inspections of XENEX Disinfection Services Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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