FDA Inspection
Sun Nuclear CorporationSun Nuclear Corporation – FDA Inspection, Sep 28, 2012
Record Details
This FDA Inspection record concerns Sun Nuclear Corporation, with an inspection on September 28, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sun Nuclear Corporation
- Inspection Date
- September 28, 2012
- Product Type
- Devices
View Company Profile
ID · 2afb3c40-116d-48b0-8dc1-add992c733ea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 801795
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.100(b)Documentation
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 820.30(g)Design validation - software validation documentation
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.30(g)Design validation - documentation
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Other FDA inspections of Sun Nuclear Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 26, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 30, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sun Nuclear Corporation
- FDA Inspection 789124 - 2012-06-26
- FDA Inspection 579182 - 2009-04-30
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