FDA Inspection
Fukuda Denshi Co, LtdFukuda Denshi Co, Ltd – FDA Inspection, Nov 4, 2011
Record Details
This FDA Inspection record concerns Fukuda Denshi Co, Ltd, with an inspection on November 4, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Fukuda Denshi Co, Ltd
- Inspection Date
- November 4, 2011
- Product Type
- Devices
View Company Profile
ID · 5545bc9c-4936-46f9-ab60-6a898aef4257
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 755756
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable
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