FDA EIR - AvKARE - August 23, 2022

An FDA inspection of AvKare, LLC, a pharmaceutical own label distributor in Pulaski, TN, was conducted from August 22-23, 2022. The routine surveillance inspection, under Compliance Program 7353.001, focused on Postmarketing Adverse Drug Experience (PADE) reporting compliance. AvKare repackages and labels approved and unapproved prescription and non-prescription drug products.

Although no formal FDA-483 observations were issued, five critical discussion items were noted. Key issues included Standard Operating Procedures (SOPs) not fully capturing current practices or regulatory requirements for adverse event (AE) reporting, such as social media monitoring, record retention, and handling of off-hours data. AvKare also lacked an FDA account for electronic submission of serious AEs for its OTC Monograph drugs where it is listed as the labeler. Furthermore, one potential AE was misclassified as a complaint and not forwarded, and documentation for forwarding three AEs to applicants was incomplete. Finally, not all relevant personnel, particularly sales and some marketing/customer service staff, were adequately trained on AE handling.

AvKare management acknowledged these issues and committed to implementing significant corrective actions. These include updating SOPs to reflect all regulatory details, establishing an electronic submission account with the FDA, revising OTC monograph labels to include manufacturer names, enhancing documentation practices for AE forwarding, and providing comprehensive training to all staff who might receive AE information. These actions aim to improve compliance with PADE reporting laws and regulations under the Food, Drug, and Cosmetic Act.