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Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with the Act. [1]
The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
The Kalkines warning is an advisement of rights usually administered by United States federal government agents to federal employees and contractors in internal investigations. The Kalkines warning compels subjects to make statements or face disciplinary action up to, and including, dismissal, but also provides suspects with criminal immunity ...
The following is a list of the 20 largest settlements reached between the United States Department of Justice and pharmaceutical companies from 2001 to 2013, ordered by the size of the total settlement.
Counseling statements, the least severe form of disciplinary action, serve as warnings for violations. [2] Counseling statements generally include the exact violation and show how one can prevent committing that violation in the future, and they improve employee performance. [ 2 ]
The warning to healthcare providers followed the company's recall over incompatibility concerns with syringe pumps. (Reporting by Pratik Jain in Bengaluru; Editing by Shilpi Majumdar and Sriraj ...
The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...
However, Fortune has learned that workers in the U.S. apparently received prior warning about not complying with the company’s return-to-work policy, before being sent a formal letter of education.
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