From the FDA Law Blog – Feb 2, 2011 (reference below):
“… a corporate official can be convicted of a misdemeanor based solely on his position of responsibility and control to prevent the underlying violation of the FDCA. There is no requirement that the official acted personally in the wrongdoing, or that he even had knowledge of it. The Supreme Court determined that the FDCA “imposes not only a positive duty to seek out and remedy violations when they occur but also, and primarily, a duty to implement measures that will insure that violations will not occur.” Park, 421 U.S. at 672.”This is not limited to the processors, but to those who utilize contract manufacturers. From the FDA Law Blog – May 28, 2013 (reference below):
“The letters cite Park and Dotterweich to support the legal theory that a distributor that uses contract manufacturers or labelers may be liable (or convictable) for Current Good Manufacturing Practice ("CGMP") violations by its contractors.”
This is different than the PCA Peanut Butter cases, where officials knew they were shipping contaminated product. As seen in the Jensen case, it is more of a point that they should have known and taken preventive actions.
FDA Law Blog
February 06, 2011
FDA Finally Releases “Non-binding” Park Doctrine Criteria
By Anne K. Walsh –
Eleven months after telling Senator Grassley (in a letter available here) that “[c]riteria now have been developed for consideration in selection of misdemeanor prosecution cases and will be incorporated into the revised policies and procedures that cover appropriate use of misdemeanor prosecutions,” FDA just last week finally released those criteria. The idea behind such criteria is to increase misdemeanor prosecutions against corporate officials under the Park doctrine.