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

Executive Summary

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.

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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.

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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