ME Center (Nagaizumi) of Terumo Corp – FDA Inspection, Nov 2, 2017

Record Details

This FDA Inspection record concerns ME Center (Nagaizumi) of Terumo Corp, with an inspection on November 2, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: ME Center (Nagaizumi) of Terumo Corp
Inspection Date: November 2, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Kwong P. Lee (Company Rep)

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ID · 974db55c-6ec9-4bb2-97a0-a4ca30f7f25b

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1032159
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.120(d)Records, DHR {see also 820.184(e)}

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FDA Inspection

ME Center (Nagaizumi) of Terumo CorpNovember 2, 2017