FDA 483 - Guangdong Sunshine Pharmaceutical Co Ltd - April 18, 2025

Guangdong Sunshine Pharmaceutical Co. Ltd. was cited for significant deficiencies in its sterile drug product manufacturing, including inadequate aseptic process validation, poor operator practices, and deficient procedures for sanitization and environmental monitoring. The firm also failed to retest active pharmaceutical ingredients for critical attributes, did not consistently follow endotoxin testing procedures, and had shortcomings in quality control unit review of production records before batch release.