FDA 483 - M.O.M Enterprises, LLC. - March 20, 2019

MOM Enterprises, Inc., an own label distributor of OTC drug products in Richmond, CA, received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in the firm's quality control unit, including failures to follow their Quality Agreement with their contract manufacturing organization (CMO) and a lack of written procedures for complaints and employee training. Additionally, the firm failed to qualify its CMO and did not adequately verify laboratory records or raw data from the CMO, indicating a lack of oversight for critical manufacturing and testing processes.