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

During an FDA inspection conducted from June 4 to June 21, 2024, ReConserve of Maryland, Inc., an animal food manufacturer, received a Form FDA 483 outlining significant observations regarding their food safety practices. The primary issues included a failure to adequately identify and evaluate known hazards, such as environmental pathogens, for their Dried Bakery Product, with an outdated and incomplete hazard analysis cited. Inspectors observed conditions leading to potential finished product recontamination, including vehicle movement and facility doors left open, exposing product to pests. Furthermore, the firm lacked established written procedures and proper monitoring for critical preventive controls, specifically failing to record dryer time at a critical control point. Verification of preventive controls was also deficient, with no established acceptance limits for finished product pathogen testing. Lastly, the company had not validated its drying process to scientifically confirm effective control of target pathogens like E.coli, salmonella, and listeria. Notably, several of these deficiencies were repeat observations from a prior inspection in June 2023. ReConserve of Maryland, Inc. is required to implement comprehensive corrective actions to address these observations and ensure compliance with food safety regulations.