FDA 483 - Athea Laboratories Inc - January 25, 2017

Athea Laboratories Inc. in Milwaukee, WI, was inspected by the FDA, resulting in two observations. The inspection revealed deficiencies in quality control procedures, specifically the failure to reject drug products that did not meet microbial specifications, and inadequate quarantine storage areas for incoming materials prior to release. These issues indicate a lack of proper controls to ensure product quality and prevent mix-ups.