FDA 483 - Safe Medical Technology Co., Ltd. - May 16, 2025

During an inspection conducted from May 12-16, 2025, the U.S. Food and Drug Administration (FDA) identified significant deficiencies at Safe Medical Technology Co., Ltd., a nonclinical laboratory located in Gu’an, Langfang, Hebei Province, China. The observations, detailed in an FDA 483 report, highlighted a range of quality system and operational non-compliances that deviate from regulatory expectations for ensuring the integrity and reliability of nonclinical study data. Key issues included a failing quality assurance unit, specifically regarding the verification of tissue samples, inadequate measurement of animal room environmental parameters, and non-adherence to national illumination standards. The inspection also found problems with the proper differentiation and identification of animals from different studies housed in proximity. Furthermore, the firm exhibited shortcomings in data integrity, with unrecorded reasons for changes in automated data entries and a failure to identify individuals making direct data inputs. Archive security was compromised due to an unlocked specimen room, and essential equipment maintenance records were not adequately retained. Issues extended to personnel, where not all study personnel received required protocol training, and study directors failed to archive critical communication documents. Lastly, sanitation concerns were noted with improper storage of clean animal cages in direct contact with walls and floors. These observations underscore a need for comprehensive corrective actions to address fundamental failures in quality management, data control, facility maintenance, and personnel oversight, aligning with the principles outlined in the Federal Food, Drug, and Cosmetic Act. The company is required to promptly respond to the FDA with a plan to rectify these identified issues.