FDA 483 - KarePak, LLC - October 09, 2019

KarePak, LLC, an OTC drug repacker and relabeler in Oakdale, CA, was cited for two observations during an FDA inspection. The firm failed to follow written procedures for equipment cleaning and maintenance, with equipment found unlabeled and not thoroughly cleaned. Additionally, the company's reserve drug product samples were insufficient, not meeting the required quantity for all necessary tests.