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

During an FDA inspection conducted from September 2nd to September 5th, 2024, GUANGDONG BIOLIGHT MEDITECH CO., LTD, a Class II medical device manufacturer in Zhuhai, China, was issued a Form FDA 483 with two significant observations regarding its quality system. The first observation noted inadequate procedures for design changes. Specifically, the company's Medical Device Lifecycle Procedure lacked essential documentation requirements for software compilation and bug mitigation, with no records of initial software writing, bug identification, or mitigation during numerous revisions for products like the M800 and M70 pulse Oximeters. The second observation cited the absence of established procedures to ensure adequate sampling methods. The firm failed to provide documented rationale, such as statistical or risk-based justification, for sample sizes used in design and process validation/verification activities. These observations indicate potential non-compliance with the Federal Food, Drug, and Cosmetic Act's quality system requirements. The company is expected to evaluate these findings and implement comprehensive corrective actions to address the identified deficiencies and ensure product safety and effectiveness.