FDA Inspection
XENEX Disinfection Services Inc.XENEX Disinfection Services Inc. – FDA Inspection, Oct 31, 2023
Record Details
This FDA Inspection record concerns XENEX Disinfection Services Inc., with an inspection on October 31, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cd822615-67c5-4881-bea6-1e55dbc6af58
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1221527
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of XENEX Disinfection Services Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2019 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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