FDA Inspection
James J. YueJames J. Yue – FDA Inspection, Mar 21, 2013
Record Details
This FDA Inspection record concerns James J. Yue, with an inspection on March 21, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- James J. Yue
- Inspection Date
- March 21, 2013
- Product Type
- Devices
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ID · 47275d31-aa8c-4809-8641-7500ca8d20a3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 828084
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate
- 21 CFR 812.140(a)(1)Investigator correspondence records inadequate
- 21 CFR 812.100No investigator protection - subject rights, safety, welfare
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