FDA 483 - Sanitation & Environmental Technology Institute - March 15, 2024

During an FDA inspection conducted from March 6 to March 15, 2024, at Sanitation & Environmental Technology Institute, a non-clinical laboratory in Suzhou, China, significant violations of FDA Good Laboratory Practice (GLP) regulations were observed. The inspection revealed pervasive deficiencies across multiple areas critical to data quality and integrity. Main issues included a systemic breakdown in the Quality Assurance Unit’s oversight, such as failing to communicate deviations, accurately audit reports, or ensure compliance with standard operating procedures (SOPs). Study directors similarly failed to maintain overall control of studies, document unforeseen circumstances, or ensure complete data archival. Data integrity was compromised by duplicated data, inadequate investigations, and discrepancies between raw data and final reports. Furthermore, the facility exhibited inadequate animal care and welfare practices, lacking proper SOPs for monitoring, euthanasia, and veterinary treatment, leading to untreated animal conditions and insufficient identification. Protocols and SOPs were routinely disregarded, and comprehensive written procedures for critical study methods were absent. Storage conditions for specimens were compromised, and personnel lacked adequate documented training. Unauthorized access to archives and poor data recording practices were also noted. These observations indicate a need for urgent and comprehensive corrective actions by Sanitation & Environmental Technology Institute to ensure full adherence to regulatory requirements and the reliability of their non-clinical laboratory studies.