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

An FDA inspection of Acella Pharmaceuticals, LLC, an own-label distributor of pharmaceutical and dietary supplement products, occurred from December 17, 2019, to January 7, 2020, in Alpharetta, GA. The inspection, conducted under drug manufacturing compliance programs, identified significant violations of current Good Manufacturing Practices (cGMP) regulations, particularly 21 CFR 211.22(a). The primary issues highlighted in the FDA-483 included the absence of an adequate quality control unit. Acella failed to ensure product quality upon release, merely reviewing contractor documents for NP Thyroid without verifying test data. The firm also inadequately investigated over 80 customer complaints concerning "odor" or "taste" of NP Thyroid tablets, failing to include all supply chain parties or determine root causes. Furthermore, over 74% of complaints lacked lot numbers and received insufficient investigation from both the contract manufacturer and Acella. A critical finding was the deficiency in complaint procedures, specifically regarding adverse event reporting. Numerous serious patient experiences, such as heart palpitations and severe TSH level changes, were improperly classified as "non-serious, unexpected" by a third-party, leading to underreporting to the FDA. Acella also neglected to reply to complainants, even when requested, for hundreds of cases, and this requirement was absent from their procedures. Additionally, a verbal observation noted the lack of temperature control during the transportation of drug product components and finished goods. Acella's Senior Vice President promised corrective actions and a written response to address these systemic issues, which span quality control, complaint handling, adverse event reporting, and supply chain oversight.