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Talk to a SpecialistTalk to a SpecialistCCIC Huatongwei International Inspection Co., Ltd., a nonclinical laboratory testing facility in China, failed to comply with Good Laboratory Practice (GLP) regulations during FDA inspection of multiple biocompatibility and toxicity studies conducted January 6-14, 2025. The inspection focused on studies including rabbit muscle implantation, guinea pig maximization tests, acute systemic toxicity, MTT cytotoxicity, rabbit pyrogen, intracutaneous reactivity, and hemolysis tests used in the development of medical devices. The FDA identified objectionable conditions and violations in how these nonclinical studies were conducted and documented, though the specific compliance failures are redacted in the available letter excerpt.