Guangzhou Lvying Biotechnology Co., Ltd – FDA Warning Letter, May 1, 2026

On October 27, 2026, the FDA issued a warning letter to Guangzhou Jiugong Research And Development Biotechnology Co., Ltd. following a review of manufacturing records requested in May 2026. The review revealed that the company is in violation of the Federal Food, Drug, and Cosmetic Act and Current Good Manufacturing Practice (CGMP) regulations. A primary issue identified was the use of FD&C Red No. 2 (CI 16185) in over-the-counter drug products. This color additive was banned in 1976 due to safety concerns, making the products adulterated under federal law. Additionally, the FDA found that the company"s quality department failed to provide adequate oversight, leading to significant discrepancies between product labels, formulation records, and ingredient certificates. The company further failed to respond to the agency"s repeated requests for clarification on these issues. To resolve these violations, the FDA requires the company to submit a comprehensive remediation plan to improve its quality oversight and documentation practices. The company must also provide a risk assessment for all drug formulations, a list of all products and customers in the U.S. market from the last three years, and a plan for potential product recalls. Failure to address these concerns promptly may lead to the FDA blocking the company"s products from entering the United States.