How The US FDA Is Checking For Adequate Controls Against DEG/EG Ingredient Substitution
Agency has increased its efforts to protect the US market from the diethylene glycol and ethylene glycol adulteration linked to hundreds of deaths in seven countries with testing, remote records requests, inspections, import alerts and more. Manufacturing quality compliance director Francis Godwin stresses importance of testing every container, while sharing tips for simplifying the task.
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One of firms targeted in eight most recent warnings published since early September to OTC drug manufacturers, Zhao Qing Longda Biotechnology Co. in China, was dinged for both failing to respond to a request for records and for concerns about its production with DEG and EG.
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.
Substantial revision of 2007 DEG guidance comes after hundreds of deaths in seven countries that were linked to diethylene glycol and ethylene glycol adulteration. All containers and all lots of certain additional excipients must now be tested, and many others should be.