FDA Inspection
He Gao Plastic FactoryHe Gao Plastic Factory – FDA Inspection, Mar 14, 2013
Record Details
This FDA Inspection record concerns He Gao Plastic Factory, with an inspection on March 14, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- He Gao Plastic Factory
- Inspection Date
- March 14, 2013
- Product Type
- Devices
View Company Profile
ID · 7944bcce-85d1-441a-bbb5-5cd9a0c54e4d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 825428
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.86Acceptance status
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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Other FDA inspections of He Gao Plastic Factory
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2016 | Not classified | Office of Inspections and Investigations | |
| December 21, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for He Gao Plastic Factory
- FDA Inspection 992549 - 2016-11-09
- FDA Inspection 762201 - 2011-12-21
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