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

Macau-Union Pharmaceutical Limited received an FDA warning letter following an inspection of its Macao facility from December 15 to 17, 2025. The investigation revealed significant failures to comply with Current Good Manufacturing Practice (CGMP) regulations under the Federal Food, Drug, and Cosmetic Act. Primary violations included the distribution of over-the-counter drug products without testing for identity, strength, or microbial purity. Additionally, the company failed to verify the quality of raw materials from suppliers, lacked validated manufacturing and equipment cleaning processes, and could not provide stability data to support product expiration dates. The FDA also identified two products, Bamboo Pharmacy® Mobility and Relief + Recovery rubs, as unapproved new drugs. These products contained unauthorized ingredients and made medicinal claims, such as reducing inflammation, that exceeded the limits of the applicable regulatory monograph. Consequently, the firm"s products were placed on an import alert in March 2026. To address these issues, the FDA requires the company to provide comprehensive remediation plans, including retrospective testing of distributed batches and a complete overhaul of their quality systems. The agency strongly recommends hiring an independent consultant to assist in meeting compliance standards. Macau-Union Pharmaceutical Limited must submit a written response outlining their corrective actions within 15 working days.