FDA Inspection
Health-Mor, IncHealth-Mor, Inc – FDA Inspection, Jan 15, 2010
Record Details
This FDA Inspection record concerns Health-Mor, Inc, with an inspection on January 15, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Health-Mor, Inc
- Inspection Date
- January 15, 2010
- Product Type
- Devices
View Company Profile
ID · feda6c81-a068-4592-8255-3a17f716c7da
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 638728
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
11- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.198(a)Complete files maintained
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.184(d)Acceptance records
- 21 CFR 820.181(a)DMR device specifications
- 21 CFR 820.50(a)(1)Documented evaluation
Showing 10 of 11 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 4, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 29, 2011 | NAI | 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 784931 - 2012-06-04
- FDA Inspection 733226 - 2011-06-29
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