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Wickimed Medical Equipment Manufacturing Co., Ltd., a Chinese manufacturer of Class II sterile single-use disposable electrodes, failed to comply with current good manufacturing practice (CGMP) requirements under 21 CFR Part 820 during an FDA inspection in September 2021. Key violations included failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints through a formally designated unit as required by 21 CFR 820.198(a). The company's responses to the FDA's Form 483 observations, submitted after the required fifteen business day deadline, were not timely reviewed with the initial warning letter.