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

An FDA inspection of InnoStar Bio-Tech Nantong Company, Ltd. in Nantong City, China, was conducted from October 28 to November 1, 2024. This initial, routine surveillance inspection evaluated the firm's adherence to Good Laboratory Practice (GLP) regulations, specifically 21 CFR Part 58, governing nonclinical laboratory studies. The inspection team identified several significant regulatory deviations. The main issues cited on a Form FDA 483 included: a lack of proper documentation for organ re-weighing, where original weights and reasons for re-weighing were not retained (Observation #1A); inadequate maintenance of facility equipment, specifically that automatic watering system cage racks were not drained during cleaning and sanitizing procedures (Observation #1C); and a failure to retain reserve samples of test articles for studies exceeding four weeks duration, as stipulated by 21 CFR 58.195 (Observation #2). These observations highlight deficiencies in procedures critical for ensuring the quality and integrity of data generated in nonclinical studies. In response to the inspectional observations, InnoStar Bio-Tech Nantong Company, Ltd. management committed to submitting a written response with detailed corrective actions within fifteen business days. The firm was also reminded of its fundamental requirement to adhere to all applicable regulatory standards to maintain compliance.