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InnoStar Nantong Facility Successfully Passed U.S. FDA GLP Inspection
2025-04-30

We are pleased to announce that Nantong facility (a wholly-owned subsidiary of InnoStar) has successfully passed the U.S. Food and Drug Administration (FDA) Good Laboratory Practice (GLP) inspection. The FDA issued an Establishment Inspection Report (EIR), confirming that InnoStar Nantong’s quality systems and operations fully comply with global regulatory standards. This milestone reinforces our commitment to delivering world-class non-clinical research services to the pharmaceutical industry worldwide.

From October 28 to November 1, 2024, the FDA conducted a rigorous on-site inspection of InnoStar Nantong’s facilities, quality management, data integrity, and experimental protocols. This marks InnoStar Nantong facility passed the first FDA GLP inspection successfully,complementing its existing accreditations from NMPA(China) and the OECD. This achievement positions InnoStar Nantong facility among a select group of CROs globally to hold this trio of internationally recognized certifications, enabling seamless support for multi-regional drug development programs under a unified quality framework.

InnoStar is a full-service Contract Research Organization (CRO) offering integrated solutions spanning early-stage drug screening, non-clinical PK/PD/toxicity studies, and clinical translation.  

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