FDA 483 - Acella Pharmaceuticals, LLC - December 18, 2024

Acella Pharmaceuticals, LLC, an Own Label Distributor in Alpharetta, GA, was cited for significant failures in regulatory reporting. The inspection revealed multiple instances where annual and quarterly periodic adverse drug experience reports (PADERS) and general annual reports for various drug products were not submitted within the required timelines to the FDA. This indicates a systemic issue with timely submission of critical post-market surveillance and regulatory compliance documents.