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Foreign OTC Firms Fail US FDA Review Of Records For Diethylene Glycol Testing, Or Fail To Reply

 
• By Malcolm Spicer

Two firms in India, two in South Korea manufacturing toothpastes and hand sanitizers available in US didn’t respond to FDA’s repeated records requests. Six others in those two countries and Canada and Turkey making sanitizers and toothpastes, including products for children, as well as sunscreens were warned about GMP failures after providing records at agency’s request.

• Source: Shutterstock

Four foreign firms producing OTC drugs susceptible to diethylene glycol and ethylene glycol substitution failed to reply to US regulators’ recent requests for information on their good manufacturing practices compliance while another six were warned about GMP violations concerning testing for the substances.

Warning letters recently published by the Food and Drug Administration include two to firms in India and two in South Korea registered as manufacturers of toothpastes and hand sanitizers available in the

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