FDA 483 - Atlantic Animal Health, Inc. dba Squire Laboratories - March 16, 2023

An FDA inspection of Atlantic Animal Health, Inc. dba Squire Laboratories in Revere, MA, a manufacturer of OTC animal drugs, revealed a repeat observation regarding deficient establishment of component supplier reliability. The firm failed to qualify suppliers for critical components and did not establish the reliability of analytical methods supporting Certificates of Analysis for drug substances like Nitrofurazone.