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Talk to a SpecialistTalk to a SpecialistSanitation & Environmental Technology Institute (SDWH), a China-based medical device testing facility, failed to comply with Good Laboratory Practice (GLP) regulations for nonclinical studies during an FDA inspection conducted March 6-15, 2024. The inspection by the FDA's Office of Bioresearch Monitoring Operations identified objectionable conditions related to multiple biocompatibility and toxicity studies, including guinea pig sensitization tests, acute systemic toxicity, complement activation, hemolysis, and cytotoxicity assays that support medical device development and regulatory submissions. The violations indicate the facility's nonclinical testing procedures and activities did not meet applicable federal standards required for supporting Investigational Device Exemptions and Premarket Approval Applications.