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

An FDA inspection of Acella Pharmaceuticals, LLC, located in Alpharetta, GA, was conducted from December 9 to December 18, 2024. The inspection revealed multiple instances of non-compliance with regulatory reporting requirements under the Federal Food, Drug, and Cosmetic Act. The primary issues identified centered on the untimely submission of various critical reports for several approved drug products.

Specifically, Acella Pharmaceuticals failed to submit annual periodic adverse drug experience reports (PADERs) for products such as Phenytoin Sodium Injection, Benzonatate, Brompheniramine Maleate/Pseudoephedrine Hydrochloride/Dextromethorphan Hydrobromide Syrup, and Doxycycline Hyclate Tablets within the mandated 60 days of their anniversary approval dates, covering reporting periods from 2020 to 2023. Additionally, quarterly PADERs for Doxycycline Hyclate Tablets were not submitted within 30 days of the close of multiple quarters in 2020, 2021, and 2022. Furthermore, annual reports for Gabapentin Oral Solution, Phenytoin Sodium Injection, Benzonatate, Brompheniramine Maleate combination syrup, and Doxycycline Hyclate Tablets were also submitted late, past their 60-day due dates, for various years between 2020 and 2023.

These observations necessitate that Acella Pharmaceuticals implement robust corrective actions to ensure all future regulatory submissions, including adverse drug experience reports and annual product updates, are submitted promptly and in full adherence to federal timelines.