Guangdong bangze medicine co., ltd – FDA Warning Letter

On October 26, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Guangdong Bangze Medicine Co., Ltd. following a records review initiated in January 2026. The review of the firm’s over-the-counter (OTC) drug manufacturing facility in China revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations, rendering their products adulterated under the Federal Food, Drug, and Cosmetic Act. The primary violations included a failure to test raw materials for identity and purity, specifically neglecting safety limit tests for high-risk ingredients that could be contaminated with lethal toxins like diethylene glycol. Additionally, the firm failed to test finished drug products for strength, identity, and microbial contamination prior to release. The company’s Quality Unit also failed to provide adequate oversight of stability programs and production processes. Due to these safety concerns, the FDA placed the firm on an Import Alert in August 2026, blocking their products from entering the United States. To address these issues, the FDA requires the company to hire a qualified consultant, perform a comprehensive audit of their operations, and submit a detailed corrective action plan within 15 business days.