Mid-Link Testing Company, Ltd

Warning LetterOpen

Xiaoming (Diana) Hong President Mid-Link Testing Company, Ltd Rongda Science Park No 51 1/F Block B 9th Street Tianjin Shi , 300457 ChinaIssued Sep 10, 2024Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations6

Issue DateSep 10, 2024

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Mid-Link Testing Company, Ltd
Location: Xiaoming (Diana) Hong President Mid-Link Testing Company, Ltd Rongda Science Park No 51 1/F Block B 9th Street Tianjin Shi , 300457 China
FEI Number: N/A
Country: China
Issue Date: September 10, 2024
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Mid-Link Testing Company, Ltd, a medical device testing facility in China, was cited for objectionable conditions related to Good Laboratory Practice (GLP) nonclinical studies conducted between February 26 and March 6, 2024. The FDA's Office of Bioresearch Monitoring Operations identified violations in acute systemic toxicity tests, rabbit pyrogen tests, MTT cytotoxicity assays, and guinea pig maximization tests (GPMT) that support investigational device exemptions and premarket approval applications. These compliance failures raised concerns about the scientific validity of data submitted to the FDA for medical device development. The company was required to provide prompt corrective actions in response to the violations documented during the inspection.

Mid-Link Testing Company, Ltd FDA Warning Letter, September 10, 2024