FDA Inspection
GF Health Products, IncGF Health Products, Inc – FDA Inspection, Sep 23, 2011
Record Details
This FDA Inspection record concerns GF Health Products, Inc, with an inspection on September 23, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- GF Health Products, Inc
- Inspection Date
- September 23, 2011
- Product Type
- Devices
View Company Profile
ID · 73386a88-cc6b-4ae0-9bde-50955f3a9e22
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 746428
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)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 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.198(e)Records of complaint investigation
Showing 10 of 11 citations.
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Other FDA inspections of GF Health Products, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 12, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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