FDA 483 - AG Essence, Inc. - February 26, 2025

AG Essence, Inc. in Sandston, VA, a contract manufacturer of OTC animal drug products, was cited for significant deficiencies in its quality control and manufacturing processes. The inspection revealed failures in process validation, equipment cleaning procedures, raw material identity testing, and microbiological testing for product release. These issues collectively indicate a systemic breakdown in GMP compliance for their animal drug products, raising concerns about product quality and safety.