KOWA CO. LTD. CHOFUJuly 5, 2018

FDA 483 - KOWA CO. LTD. CHOFU - July 05, 2018

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Record Details

KOWA CO. LTD. CHOFU, a medical device manufacturer in Chofu, Tokyo, Japan, was inspected by the FDA. The inspection resulted in two observations concerning the firm's quality system. Specifically, the firm failed to establish acceptance criteria for validation activities related to a firmware change for a Class 2 fundus camera and lacked established procedures for maintaining device history records.

Company: KOWA CO. LTD. CHOFU
Inspection Date: July 5, 2018
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Jocelyn E. Massey

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ID · 7549379d-0c7e-4010-96f6-bbc52d42f306