Regulatory Focus™ > News Articles > In Focus: FDA Compliance and Enforcement

In Focus: FDA Compliance and Enforcement

Posted 01 July 2011 | By Richard Morroney, CQA, RAC 

Compliance and enforcement issues are of serious concern to medical product companies. If everyone followed the rules, why would we need the US Food and Drug Administration (FDA) to enforce them? But what are the rules and how do they apply to my particular industry or business? Do we even need rules or need FDA? I think history has proven the answer to be yes in both cases.

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