FDA 483 - Nationwide Laboratories, LLC - November 27, 2018

Nationwide Laboratories, LLC, an own label distributor, was cited for significant deficiencies in its quality system and postmarketing adverse drug experience procedures. The firm lacks a functional quality control unit, a repeat observation from 2016, and fails to follow written procedures for quality oversight. Additionally, the company has inadequate written procedures for the surveillance, receipt, evaluation, and reporting of adverse drug experiences to the FDA.