FDA 483 - Atlantic Animal Health, Inc. dba Squire Laboratories - May 03, 2019

Atlantic Animal Health, Inc. dba Squire Laboratories in Revere, MA, received a Form 483 with two observations related to manufacturing practices for Fura-Zone. The inspection revealed failures in component testing, including a repeat observation, and significant deficiencies in equipment cleaning practices and record-keeping. These issues indicate a lack of control over product quality and potential contamination risks.