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FDA Sent These Warning Letters To Pharma/Device Companies

August 20, 2019 / BARBARA W. UNGER

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’.  One of the drug warning letters is issued to a firm that recovered solvents that were used in the manufacture of the API of valsartan products that contained the multiple potential carcinogens.  Note that Swiss Medic inspected the firm 6 days before FDA did and issued a report of non-compliance.