Nemoto Kyorindo Co., Ltd. – FDA Inspection, Dec 15, 2016

Record Details

This FDA Inspection record concerns Nemoto Kyorindo Co., Ltd., with an inspection on December 15, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company: Nemoto Kyorindo Co., Ltd.
Inspection Date: December 15, 2016
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Stephen D. Eich (Company Rep)

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ID · 96a0bfc8-0553-4e0b-bd15-98f84aecd477

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 997597
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.30(g)Design validation - user needs and intended uses

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FDA Inspection

Nemoto Kyorindo Co., Ltd.December 15, 2016