FDA Inspection
G3 Medical, Inc. dba G3 PackagingG3 Medical, Inc. dba G3 Packaging – FDA Inspection, Sep 19, 2014
Record Details
This FDA Inspection record concerns G3 Medical, Inc. dba G3 Packaging, with an inspection on September 19, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 19, 2014
- Product Type
- Devices
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ID · a2b5f876-1c8e-49a9-9128-dd7e1ddfa54d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 896628
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
15- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of G3 Medical, Inc. dba G3 Packaging
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 24, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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