The most significant FDA warning letters of 2019

FDA Building 2
One key area of action for FDA warning letters in 2019 was violations that led to unacceptable levels of suspected carcinogens in high blood pressure medications and popular OTC heartburn drug Zantac and its copies. (FDA)

Warning letters issued by the FDA in 2019 ran the gamut from small companies to large and OTC drugs to finished pharmaceuticals. Given the nature of warning letters and the dangers tied to manufacturing faults, it is not really meaningful to do a ranking of the worst offenders, or anything like that. Yet many were significant for different reasons. Some are notable because of potential dangers, some for the trends they represent and others because of the impact they had on clients, hospitals and the market.

And so we are presenting you with this special report on the Most Significant Warning Letters of 2019. They are unranked, offered up instead generally in chronological order. There may be others you believe were more worthy of mention than some here, and if so, please contact me. If I get enough of those, perhaps we can do a follow-up readers’ choice.

The most significant FDA warning letters of 2019