JUUL Labs recently received a first-of-its-kind warning letter from CTP. Learn more about the warning letter and what makes it unique.
GMP expert Barbara W. Unger analyzes the major initiatives put forth in CDER’s Office of Compliance Annual Report for CY2018.
We cover three drug warning letters, one issued to a compounding pharmacy, one device warning letter, and one in the food area that is a ‘first of its kind’.
Three warning letters were posted this week in the areas we cover: two for drugs and one for device GMP violations. Akorn also announced that they received a warning letter but it has not yet been published.
Unlike last week, warning letter enforcement is sparse this week with only one drug GMP warning letter, none to compounding pharmacies and none to device firms.
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