FDA Inspection
Compass Health Brands Corp.Compass Health Brands Corp. – FDA Inspection, Apr 16, 2009
Record Details
This FDA Inspection record concerns Compass Health Brands Corp., with an inspection on April 16, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Compass Health Brands Corp.
- Inspection Date
- April 16, 2009
- Product Type
- Devices
View Company Profile
ID · 8e1c9f15-819b-4bcf-a5b5-adf5c94615e1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 577667
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.80(e)Documentation
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.198(a)General
- 21 CFR 820.20Management responsibility
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Compass Health Brands Corp.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 12, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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