FDA Inspection
HDC CorporationHDC Corporation – FDA Inspection, Jun 11, 2010
Record Details
This FDA Inspection record concerns HDC Corporation, with an inspection on June 11, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- HDC Corporation
- Inspection Date
- June 11, 2010
- Product Type
- Devices
View Company Profile
ID · c4055745-643b-44fe-aaa1-61ded1941b17
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 667434
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 803.17Lack of Written MDR Procedures
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