FDA 483 - KANG ZE INDUSTRIAL CO., LTD - June 12, 2019

Kang Ze Industrial Co., LTD, a medical device manufacturer in Dongguan, China, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate process validation for thermometer sheaths, insufficient labeling examination, and a lack of procedures for nonconforming product disposition. Additionally, the firm failed to adequately establish and document equipment calibration procedures, indicating a lack of robust quality control for their Class 2 disposable thermometer covers and sheaths.