FDA 483 - Acella Pharmaceuticals, LLC - January 07, 2020

Acella Pharmaceutical Service, LLC in Alpharetta, GA, was cited for significant deficiencies in its quality control unit and complaint handling procedures. The firm failed to adequately investigate product complaints, verify product quality data, and properly assess and report serious adverse events related to its NP Thyroid medication. Additionally, the firm did not consistently reply to complainants, even when requested.