FDA 483 - ReConserve of Maryland, Inc. - June 21, 2024

An FDA inspection of ReConserve of Maryland, Inc., an animal food manufacturer in Baltimore, revealed significant deficiencies in its hazard analysis and preventive controls for Dried Bakery Product. The firm failed to identify and evaluate foreseeable hazards, implement adequate monitoring, verify control effectiveness through product testing, and validate its drying process. These issues, many of which are repeat observations, indicate a serious lack of control over environmental pathogens and product safety.