FDA Inspection
Health-Mor, IncHealth-Mor, Inc – FDA Inspection, Jun 4, 2012
Record Details
This FDA Inspection record concerns Health-Mor, Inc, with an inspection on June 4, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Health-Mor, Inc
- Inspection Date
- June 4, 2012
- Product Type
- Devices
View Company Profile
ID · 87f7e8dd-8d01-4a1f-93d7-aae9f95ec545
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 784931
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
16- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Showing 10 of 16 citations.
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Other FDA inspections of Health-Mor, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 25, 2014 | 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 1241144 - 2024-06-14
- FDA Inspection 880227 - 2014-06-25
- FDA Inspection 733226 - 2011-06-29
- FDA Inspection 638728 - 2010-01-15
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