APEX (GUANGZHOU) TOOLS & ORTHOPEDICS COMPANYFebruary 13, 2014

FDA 483 - APEX (GUANGZHOU) TOOLS & ORTHOPEDICS COMPANY - February 13, 2014

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Record Details

An FDA inspection of APEX (GUANGZHOU) TOOLS & ORTHOPEDICS COMPANY, a medical device manufacturer in Guangzhou, China, identified one observation. The firm's procedures for the rework of nonconforming products were found to be inadequately established, specifically lacking documentation of reevaluation activities. This indicates a deficiency in their quality system regarding product control.

Company: APEX (GUANGZHOU) TOOLS & ORTHOPEDICS COMPANY
Inspection Date: February 13, 2014
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Bleta Vuniqi (investigator)
Rodney B Ross

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ID · d6ab3ea5-ad67-48e6-b037-cec465797e0c