Background: The Company faced a Consent Decree from the Department of Justice and the Food and Drug Administration
(FDA), which threatened to close down three key manufacturing and research facilities based upon an alleged failure to comply with various quality
assurance requirements.
Solution: New policies, procedures, and quality control protocols, including a confidential company hotline and
investigative office, were established to bring all facilities into compliance. A three-person leadership team was created to re-engineer its
supply chain organization, and a global compliance auditing program was instituted for all company operations, including manufacturing, research,
clinical trials, medical labeling, and promotional activities.
Result: A first-ever Global Compliance Auditing Program was created to ensure that all facilities are in full
compliance with the applicable FDA requirements. The company is now recognized as a compliance leader at its manufacturing and research facilities
worldwide.
