Criminal investigations under the Federal Food, Drug, and Cosmetic Act (FDCA) are conducted by the Office of Criminal Investigations, often in conjunction with other agencies. Wyatt & Blake have represented employees, officers, and companies in connection with FDA investigations. These investigations often focus on whether a company is complying with current Good Manufacturing Practices (cGMP) in connection with the manufacturing, packing, processing, labeling, holding of a drug or other product subject to the FDCA. Under the Supreme Court’s holding in United States v. Park, an employee of a company may be criminally liable under the FDCA if he or she was in a position of responsibility or authority with respect to the conduct at issue (regardless of his or her participation or specific knowledge of such conduct). The FDA also provides for debarment for certain offenses. Consequently, it is important that experienced counsel be obtained in connection with such investigations.