FDA WARNING_LETTER - Sangleaf Pharm., Co. Ltd. - August 08, 2023

The FDA issued a Warning Letter to Sangleaf Pharm., Co., Ltd., a South Korean manufacturer of OTC drug products, including children's toothpaste, due to a refusal to provide records. The firm was registered with the FDA, and its products contain ingredients susceptible to Diethylene Glycol (DEG) and Ethylene Glycol (EG) substitution, which have caused lethal poisoning incidents globally.

The FDA initiated a Section 704(a)(4) request for records on December 14, 2022, followed by additional attempts via email and phone, and a written request on January 27, 2023. All communications went unanswered. This refusal to permit access to records is a prohibited act under Section 301(e) of the FD&C Act.

Due to the firm's non-response, the FDA has no indication of the quality assurance level for drugs manufactured at the facility. Consequently, the FDA may withhold approval of new applications or supplements listing Sangleaf Pharm. as a drug manufacturer. Furthermore, shipments of the firm's products into the U.S. are subject to detention or refusal under Section 801(a)(3) of the FD&C Act, as they appear adulterated or misbranded. All drugs and drug products manufactured by the firm were placed on Import Alert 66-79 on March 30, 2023.

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