FDA EIR - Acella Pharmaceuticals, LLC - March 29, 2019

Acella Pharmaceuticals, LLC underwent an FDA inspection from March 25-29, 2019, focusing on Postmarketing Adverse Drug Experience (PADE) reporting. This inspection was conducted under compliance program 7353.001 by the Center for Drug Evaluation and Research, Postmarketing Safety Branch. The company, an own-label distributor of pharmaceutical products and dietary supplements, was cited for two main objectionable conditions, both repeat observations from a previous inspection. The primary violations included the late submission of annual reports for Gabapentin Oral Solution (ANDA 076403), as required by 21 CFR 314.81(b)(2). Additionally, Acella Pharmaceuticals failed to submit annual Periodic Adverse Drug Experience Reports (PADERs) within 60 days of the anniversary date for both Gabapentin Oral Solution and Phenytoin Sodium Injection (ANDA 040573), a violation of 21 CFR 314.80(c)(2). Management indicated they were attempting to secure a waiver for reporting date changes and were unclear on PADER submission responsibilities in the absence of adverse events. Beyond the formal observations, the FDA investigator discussed concerns regarding deficiencies in existing Adverse Drug Experience procedures, outdated quality agreements with contract manufacturers, and incorrect reporting dates on aggregate reports. Acella Pharmaceuticals management acknowledged these issues and committed to providing a written response to the FDA within 15 business days. The firm also initiated voluntary corrections during the inspection, including revising draft procedures and correcting dates on certain PADERs.