FDA Inspection
Health-Mor, IncHealth-Mor, Inc – FDA Inspection, Jun 14, 2024
Record Details
This FDA Inspection record concerns Health-Mor, Inc, with an inspection on June 14, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b9890967-5330-4ecf-b260-4fdd0115d0d6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1241144
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Health-Mor, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 25, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 4, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 29, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 15, 2010 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Health-Mor, Inc
- FDA Inspection 880227 - 2014-06-25
- FDA Inspection 784931 - 2012-06-04
- FDA Inspection 733226 - 2011-06-29
- FDA Inspection 638728 - 2010-01-15
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