FDA End-of-Year Release of Warning Letters Impresses (or Depresses)
FDA Law Blog
JANUARY 1, 2024
The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. Two device manufacturers received Warning Letters for QSR violations (QSR is FDA’s label for cGMP requirements applicable to medical device manufacturers).
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