FDA 483 - SAFE Medical Technology Co., LtD. - May 12, 2025

The FDA inspected Safe Medical Technology Co., Ltd., a nonclinical laboratory in Gu'an, China, and issued a Form 483 with nine observations. Deficiencies were noted across quality assurance, data integrity, record keeping, facility maintenance, and personnel training. These issues highlight a systemic failure to adhere to established protocols and maintain adequate documentation for nonclinical studies.