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

Source: https://www.keypedia.com/records/483/sanitation-environmental-technology-institute/12b3fba6-1990-4c37-9361-52082e0e9c07

> FDA 483 for Sanitation & Environmental Technology Institute on March 15, 2024. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sanitation & Environmental Technology Institute
- Inspection Date: 2024-03-15
- Product Type: devices
- Office Name: Office of Regulatory Affairs
- Summary: During an inspection conducted from March 6 to March 15, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Sanitation & Environmental Technology Institute, a non-clinical laboratory in Suzhou, Jiangsu, China. The inspection revealed numerous objectionable conditions and practices indicating non-compliance with FDA Good Laboratory Practice (GLP) regulations and international standards such as ISO 10993. Key violations centered on significant deficiencies in the firm’s Quality Assurance Unit (QAU) and study director responsibilities. Observations included failures to communicate and document deviations, inadequate investigations into data duplication, and a lack of proper training for key personnel. The QAU consistently failed to ensure accurate reporting, review final study reports against raw data, and verify protocol adherence. Study directors neglected to manage unforeseen circumstances, ensure complete data archiving, and maintain overall study control, including unauthorized changes to test material descriptions. Further issues involved compromised data integrity due to missing or inaccurate records, improper specimen identification and storage, and a lack of established or adhered-to Standard Operating Procedures (SOPs) for critical processes like animal care, monitoring, and data collection. Animal welfare was also a concern, with inadequate procedures for health evaluation, isolation, and medical treatment of test animals. Unauthorized personnel accessing archives and raw data not being recorded promptly were also noted. These findings highlight a systemic breakdown in the institute's quality system and its ability to assure the reliability and integrity of non-clinical study data. The firm is required to implement comprehensive corrective and preventive actions to address all observations, ensuring compliance with regulatory frameworks and safeguarding the quality of future studies.

## Related Documents

- [483 - 2024-03-15](https://www.keypedia.com/records/483/sanitation-environmental-technology-institute/e5017a61-f8b3-4b80-aaa4-c3b3526e398c)

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Company: https://www.keypedia.com/companies/sanitation-environmental-technology-institute/a947f265-e94c-4ec2-ae51-69adb6b413c4

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