KM Pharmaceutical Co. Ltd.

Your firm is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products, including (b)(4) and hand sanitizer. Ingredients of the drugs registered as manufactured at your firm include ingredients susceptible to Diethylene Glycol (DEG) and Ethylene Glycol (EG) substitution. A review of import records showed multiple shipments of drug products into the United States, which declared KM Pharmaceutical Co. Ltd. as the drug manufacturer. On March 3, 2023, the FDA sent an electronic request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4), to the contact e-mail address provided in your registration file. This request ultimately went unanswered. A second request was sent via e-mail on March 16, 2023, followed by an attempted contact by telephone with your registered U.S. Agent on April 12, 2023, regarding this matter. The Agency sent a follow-up written request for such records and other information on April 17, 2023. Delivery to you was confirmed by the shipper, but you failed to respond to these attempted communications or otherwise provide the requested records or other information. Pursuant to section 704(a)(4), FDA’s request and follow-up communication included a sufficient and clear description of the records sought.

It is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to refuse to permit access to or copying of any record as required by section 704(a).

The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol to help you meet the current good manufacturing practice (CGMP) requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.

Because your firm failed to respond to the section 704(a)(4) records requests and associated communication attempts, we have no indication of the level of quality assurance for drugs registered as manufactured at your facility.

Until FDA is able to confirm compliance with CGMP and other applicable requirements, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at KM Pharmaceutical Co. Ltd., 121 Pyeongtaekhang-ro, 268 beon-gil, Poseung-eup, Pyeongtaek Gyeonggi, 17953 South Korea, into the United States that appear to be adulterated or misbranded are subject to being detained or refused admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).

FDA placed all drugs and drug products manufactured by your firm on Import Alert 66-79 on June 7, 2023.

After you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may provide information for our consideration as we continue to assess your activities and practices, and/or submit a request to schedule an FDA inspection.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI #3010164172 and ATTN: Matthew R. Dionne, Pharm.D., Compliance Officer.