FDA 483 - Sunshine Lake Pharma Co., Ltd - March 22, 2024

An FDA inspection of Sunshine Lake Pharma Co., Ltd. in Dongguan, China, revealed a significant failure in their quality management system. The firm's Quality Unit did not adhere to written procedures for annual product quality reviews, specifically neglecting to track and review 64 quality deviations over a period of several years. This indicates a lack of adequate oversight regarding product quality and deviation management.