FDA 483 - Macau-Union Pharmaceutical Limited - December 17, 2025

Macau-Union Pharmaceutical Limited, a drug manufacturer in Macau, was cited with eight observations during an FDA inspection. The firm demonstrated significant deficiencies across its quality control system, including a lack of finished product testing, component identity and quality testing, process validation, and stability testing. These issues indicate a systemic failure to ensure the quality, purity, and strength of drug products intended for the U.S. market.