FDA slaps Florida's Allay Pharmaceuticals with warning letter over vague responses to drug potency issues
Inadequate responses to findings of potency discrepancies, blending issues and out-of-specification samples during a May 2020 inspection recently landed tablet manufacturer Allay Pharmaceuticals with a scorching FDA warning letter.
In a heavily-redacted version of the Jan 27 letter that was made available this week, the FDA chided the Hialeah, Florida manufacturer for vague and insufficient responses across the board to three major observations discovered during the May 5 to 15, 2020 site inspection. Those observations were communicated through a Form 483 letter, and Allay’s responses to the FDA on June 6 clearly irked the agency.
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