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How The US FDA Is Checking For Adequate Controls Against DEG/EG Ingredient Substitution

Executive Summary

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

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.

Revised US FDA Guidance Calls For Testing More Excipients For DEG And EG

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