The following article makes generalized statements, and is not intended to be understood as all inclusive, absolutely complete, or to be applicable in absolutely every situation. Its purpose is to provide a framework on which to build a better, deeper understanding of what compliance is.

Regulatory Agencies; who they are and what they do.

Regulatory Agencies are entities that have authority to establish rules, regulations, guidance, and criteria that manufacturers should or must comply with. Failure to comply, or failure to meet established criteria, can result in product recalls, warnings, fines, consent decrees, cease-and-desist orders, injunctions, and in the worst of cases, adverse events, criminal charges and jail time if convicted.