FDA 483 - InnoStar Bio-Tech Nantong Company, Ltd. - November 01, 2024

An FDA inspection of InnoStar Bio-Tech Nantong Co. Ltd., a nonclinical laboratory in Nantong City, China, revealed significant deficiencies. The firm was cited for inadequate written standard operating procedures that compromised data quality and integrity, and for failing to retain reserve samples of test articles for long-duration studies. These issues indicate a lack of control over critical study processes and regulatory compliance.