483
Hangzhou AGS Meditech Co., Ltd.Hangzhou AGS Meditech Co., Ltd. – FDA 483, May 2, 2019
Record Details
An FDA inspection of Hangzhou AGS MedTech Co. Ltd. in Hangzhou, China, revealed significant deficiencies in the firm's quality system. Observations included inadequate procedures for the rework of non-conforming products and a failure to adequately establish CAPA procedures, resulting in continued product complaints without verified corrective actions.
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ID · a3a29e2f-f84d-4dd7-9c0f-046cef1483b6
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