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Navigating Loss Reporting: How to Meet FDA and State Reporting Requirements
Thought Leadership Sales and Marketing Compliance
by Anne E. Wagstaff, John E. Niznik and Rhonda Sobral O'Toole
When a manufacturer discovers theft, “significant loss,” record falsification or diversion of its product, it has an obligation to report the discovery to the FDA and the appropriate state agency. Failure to do so can result in the imposition of fines and possibly sanctions. Unfortunately, reporting a loss is not as easy as it would seem.
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