FDA issues Warning letters to several Firms for failure to test contaminants Diethylene Glycol (DEG), Ethylene Glycol (EG) in input materials Propylene Glycol, Glycerine, Sorbitol – LCC , Sangleaf Pharm , KM Pharma (South Korea), Orchid Life Sciences , Skyline Herbals , Daxal Cosmetics , Suhan Aerosol , Medgel (India), Tan Alize Kozmetik (Turkey), Avaria (Canada), Avlon (USA)

Several manufacturers of OTC drug products including mouthwash, toothpaste, topical analgesics, Sunscreen products, Hand Sanitizers and capsules were issued Warning letters for failure to test contaminants Diethylene Glycol (DEG), Ethylene Glycol in input components. The Firms failed to demonstrate that they adequately tested incoming components at high risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination. The incoming components include Propylene Glycol, Glycerine, Sorbitol. The Warning letters are issued because deficiencies were observed during review of records provided to FDA, inadequate response to FDA observations (483s) during inspection and / or failure of Firms to provide information to FDA. FDA expects Firms to comply with guideline Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol. Use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. Firms which failed to respond to FDA include Skyline Herbals (India), Daxan Cosmetic(India), KM Pharma (Korea), Sangleaf Pharm (Korea).

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LCC, Sangleaf Pharm, KM Pharma, Orchid Life Sciences, Skyline Herbals, Daxal Cosmetics, Suhan Aerosol, Medgel, Tan Alize Kozmetik, Avaria, Avlon