Jiangsu Kerbio Medical Technology Group Co.

Warning LetterOpen

Mr. Shangyou Lin Chief Executive Officer, General Manager Jiangsu Kerbio Medical Technology Group Co. Chang yang Rd., No. 9, C4 Building Wujin Qu Changzhou Shi Jiangsu Sheng , 213145 ChinaIssued Jul 11, 2025Center for Devices and Radiological Health

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

Violations11

Issue DateJul 11, 2025

Product TypeOther

StatusOpen

Letter Details

Firm: Jiangsu Kerbio Medical Technology Group Co.
Location: Mr. Shangyou Lin Chief Executive Officer, General Manager Jiangsu Kerbio Medical Technology Group Co. Chang yang Rd., No. 9, C4 Building Wujin Qu Changzhou Shi Jiangsu Sheng , 213145 China
FEI Number: N/A
Country: China
Issue Date: July 11, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Other
Status: Open

Summary

Jiangsu Kerbio Medical Technology Group Co., a medical device manufacturer in China, was cited for objectionable conditions in Good Laboratory Practice (GLP) nonclinical laboratory studies conducted at their facility. An FDA inspection from January 15-24, 2025, identified compliance failures across multiple biocompatibility and toxicity testing studies, including guinea pig maximization sensitization (GPMT), acute systemic toxicity (AST), rabbit pyrogen, muscle implantation, hemolysis, intracutaneous reactivity, and cytotoxicity tests. The violations indicated that the company's nonclinical study activities and procedures did not comply with applicable federal GLP regulations.

Jiangsu Kerbio Medical Technology Group Co. FDA Warning Letter, July 11, 2025