Guangdong Bisutang Biotechnology Co., Ltd. – FDA Warning Letter

The FDA issued a warning letter dated October 27, 2026, to Guangdong Bisutang Biotechnology Co., Ltd. following a regulatory review of its manufacturing records. The company, based in China, produces over-the-counter drugs such as sunscreen and various cosmetic products. The primary violation cited is the firm"s failure to respond to multiple FDA requests for manufacturing records between May and May 2026. This refusal to provide documentation is a prohibited act under the Federal Food, Drug, and Cosmetic (FD&C) Act and prevents the FDA from verifying the quality of the drugs being produced. Additionally, the FDA identified that the firm’s "XUEYI SKIN CARE" sunscreen contains a cancelled color additive, Ext. D&C Yellow No. 5 (CI 11680), which was delisted in 1966 due to safety concerns. The use of this unsafe additive renders the product adulterated under federal law. Consequently, the FDA placed all of the company"s drug products on Import Alert 66-79 on July 31, 2026. The firm was also cautioned regarding import documentation discrepancies and new requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The company must respond in writing within 15 working days to outline corrective actions and may request an FDA inspection to resolve these issues.