Ricki Chase, M.S., Vice President, Lachman Consultant Services, Inc. (Lachman Consultants) and Carrie Colella, Senior Director, Lachman Consultant Services, Inc. (Lachman Consultants) take an in-depth look at the questions and challenges manufacturers face and how to respond to consumer product complaints while working with a contract manufacturing organization (CMO).
The product, in this case, may be any U.S. Food and Drug Administration (FDA) related commodity, food, drug, device, combination product, biologic, or others. The basic principles and concepts of complaint management are the same regardless of the commodity in question. The specific requirements may differ, particularly when it comes to reporting complaints that are adverse events to the FDA.
This insightful article outlines and explains the basic roles and responsibilities of each party, and the FDA, when it comes to proper and effective complaint management.