FDA Inspection
IND Diagnostic Inc.IND Diagnostic Inc. – FDA Inspection, May 20, 2010
Record Details
This FDA Inspection record concerns IND Diagnostic Inc., with an inspection on May 20, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- IND Diagnostic Inc.
- Inspection Date
- May 20, 2010
- Product Type
- Devices
View Company Profile
ID · b132d2e0-34cd-49c3-8089-505148c49fc4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 663257
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(d)(2)Review of data and documentation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.100(a)(6)Dissemination of problem information - procedure
- 21 CFR 820.184(e)ID label, labeling
- 21 CFR 820.184(b)Quantity manufactured
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