FDA WARNING_LETTER - Jiangsu Kerbio Medical Technology Group Co. - January 24, 2025

Jiangsu Kerbio Medical Technology Group Co., located in Changzhou, China, was inspected by the FDA from January 15 to January 24, 2025. The inspection aimed to assess compliance with Good Laboratory Practice (GLP) regulations under Title 21 CFR Part 58, which ensure the integrity of data submitted for device approvals. The FDA identified significant violations, particularly concerning the role of the study director, who failed to ensure adherence to study protocols, accurate data recording, and compliance with GLP regulations.

Key violations included the absence of daily animal observation records, implausible data entries indicating simultaneous activities by the same personnel, and retroactive completion of records. Additionally, discrepancies were noted in the use of previously utilized animals contrary to protocol requirements and the premature initiation of studies without proper animal acclimatization.

The FDA"s letter emphasized the need for Jiangsu Kerbio to take prompt corrective actions to address these issues. The company had responded on February 21, 2025, but the FDA found the response insufficient in resolving the cited violations. The letter serves as a formal request for Jiangsu Kerbio to implement corrective measures to ensure compliance with federal regulations and maintain the integrity of their nonclinical study data.