FDA 483 - GUANGDONG BIOLIGHT MEDITECH CO., LTD - September 05, 2024

An FDA inspection of GUANGDONG BIOLIGHT MEDITECH CO., LTD, a class II medical device manufacturer in Zhuhai, Guangdong, China, revealed two significant observations. The firm lacked adequate procedures for design changes, specifically regarding software compilation and bug mitigation for their pulse oximeters. Additionally, the company failed to establish procedures to justify sampling sizes used in design and process validation/verification activities.