Employee Training for Pharma Sector

On a cold wintry morning in December 2013 the management of a small pharmaceutical company received a stern warning letter from the Office of Compliance, Center for Drug Evaluation and Research, regarding regulatory violations found during a U.S. Food and Drug Administration’s (FDA) investigation. Along with a list of noncompliance issues detected, the letter further ordered the company to notify its office in writing of the actions the company had taken or would be taking to prevent similar violations in the future. It continued to state that, failure to adequately and promptly explain the violations noted in the letter would result in regulatory action without further notice.

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