FDA 483 - Lepu Medical Technology (Beijing) Co., Ltd. - November 23, 2023

Lepu Medical Technology (Beijing) Co., Ltd. was cited for significant quality system deficiencies during an FDA inspection. The firm failed to establish adequate corrective and preventive actions for unauthorized shipments of SARS-CoV-2 rapid test kits to the U.S., leading to a Class 1 recall. Additionally, the inspection revealed a lack of design validation for their Shoocin Introducer Kits and inadequate device history records for these products.