FDA Inspection
Applied Diabetes Research, Inc.Applied Diabetes Research, Inc. – FDA Inspection, Jul 20, 2011
Record Details
This FDA Inspection record concerns Applied Diabetes Research, Inc., with an inspection on July 20, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 20, 2011
- Product Type
- Devices
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ID · 1e67b959-6aa0-4468-8a68-c035fa82cc39
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 738434
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.184DHR content
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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