Federal Prosecution of Corporations

The relevant portion of the United States Attorneys Manual is available at http //www.usdoj. gov/usao/eousa/foia reading room/usam/title9/28mcrm.htm. 

Memorandum by Eric H. Holder to All Component Heads and United States Attorneys, Bringing Criminal Charges Against Corporations, and attachment, Federal Prosecution of Corporations (June 16, 1999). 

See DOJ Press Release, available at http //www.usdoj.gov/opa/pr/2008/August/08-odag-757. html. 

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Each company should have a policy that strictly prohibits the deliberate falsification, mutilation, obliteration, or destruction of raw data and associated GMP documentation. Companies must insist on strict adherence to such policies and should take aggressive disciplinary action when lapses are detected. Failure to do so may subject the company and its corporate officers to severe regulatory sanctions, including criminal prosecution under the Federal Food, Drug, and Cosmetic Act, or the general criminal laws of the United States (Title 18, U.S. Code). Even inadvertent (non-deliberate) acts that result in loss of data or records should be prevented, and, if they occur, they should be promptly and thoroughly investigated. 

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