FDA EIR - Acella Pharmaceuticals, LLC - March 08, 2017

The FDA conducted an inspection of Acella Pharmaceuticals, Llc, an own label distributor of drug and dietary supplement products, from March 1 to March 8, 2017. This inspection focused on the company's Postmarketing Adverse Drug Experience (PADE) reporting systems, governed by FDA regulations concerning drug safety and annual submissions.

The inspection revealed several deficiencies, documented in a Form FDA 483 with three primary observations. First, the company's written procedures for handling adverse drug experiences were incomplete, specifically lacking detailed instructions for reports received through various channels like verbal communication, electronic means, or scientific literature. Second, Acella Pharmaceuticals failed to submit annual reports for its approved drug product, Gabapentin Oral Solution, within the required 60 days of its approval anniversary date. Third, the company did not submit regular Periodic Adverse Drug Experience Reports (PADERs) for Gabapentin Oral Solution and lacked formal written procedures for these essential reports.

Additional concerns raised by the FDA included missing information in individual adverse event reports, an inadequate system for maintaining long-term adverse event records, and a non-comprehensive definition of serious adverse drug experiences in their procedures. Furthermore, operational procedures from their pharmacovigilance vendor were unapproved and inconsistent, and employee training on adverse event reporting lacked formal comprehension assessments.

Acella Pharmaceuticals' management acknowledged the findings and committed to responding to the agency in writing within 15 business days. They agreed to revise all deficient procedures, ensure timely compliance with reporting requirements, and implement an assessment program for employee training to address all identified issues.