FDA Inspection
Case Medical, Inc.Case Medical, Inc. – FDA Inspection, Oct 12, 2023
Record Details
This FDA Inspection record concerns Case Medical, Inc., with an inspection on October 12, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 805142e5-1d60-4445-bff4-3328de46d4af
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1220232
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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Other FDA inspections of Case Medical, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 29, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 23, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 24, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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