FDA 483 - M.O.M Enterprises, LLC. - November 05, 2025

MOM Enterprises, LLC, an own label distributor in Richmond, CA, was cited for significant quality control failures during an FDA inspection. Observations included failing to report serious adverse events related to infant choking incidents, not establishing adequate product specifications for botanical dietary supplements, and releasing a product batch that did not meet specifications without proper deviation documentation. These issues indicate a lack of adherence to established procedures and regulatory requirements for dietary supplement manufacturing and quality control.