Wickimed Medical Equipment Manufacturing Co., Ltd.

Warning LetterClosed

Mac Lai CEO Wickimed Medical Equipment Manufacturing Co., Ltd. XingWang Street, LiLin Town ZhongKai Hi-Tech Zone Huizhou Shi Guangdong Sheng , 516003 ChinaFEI 3010601992Issued Jan 7, 2022Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3010601992.

Violations6

Issue DateJan 7, 2022

Product TypeMedical Devices

StatusClosed

Closeout LetterJun 2, 2022

Letter Details

Firm: Wickimed Medical Equipment Manufacturing Co., Ltd.
Location: Mac Lai CEO Wickimed Medical Equipment Manufacturing Co., Ltd. XingWang Street, LiLin Town ZhongKai Hi-Tech Zone Huizhou Shi Guangdong Sheng , 516003 China
FEI Number: 3010601992
Country: China
Issue Date: January 07, 2022
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Closed
Closeout Letter: June 02, 2022

Summary

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.

Wickimed Medical Equipment Manufacturing Co., Ltd. FDA Warning Letter, January 7, 2022