FDA 483 - Acella Pharmaceuticals, LLC - March 29, 2019

An FDA inspection of Acella Pharmaceuticals, Llc in Alpharetta, GA, from March 25-29, 2019, revealed two significant issues related to regulatory reporting. The firm failed to submit annual reports for an approved drug product within the required 60-day timeframe. Additionally, not all annual Periodic Adverse Drug Experience Reports (PADERs) for multiple approved drug products were submitted within 60 days of their respective anniversary dates.