FDA Inspection
Denka Seiken Co., Ltd. - Niigata FactoryDenka Seiken Co., Ltd. - Niigata Factory – FDA Inspection, Feb 13, 2014
Record Details
This FDA Inspection record concerns Denka Seiken Co., Ltd. - Niigata Factory, with an inspection on February 13, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 13, 2014
- Product Type
- Devices
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ID · 7db0e93f-af9e-4f77-a9e2-1e2693f6f535
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 868473
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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