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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.