FDA End-of-Year Release of Warning Letters Impresses (or Depresses)
FDA Law Blog
JANUARY 1, 2024
The letter also stated that the company’s response to the inspection report was “inadequate because it did not include a review of environmental monitoring data in your manufacturing areas, an adequate risk analysis of previously manufactured drug product, or testing of reserve samples from impacted batches.” Patcos Cosmetics Pvt.
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