FDA References Park Doctrine In Warning Letter, Stirring Enforcement Debate

FDA's recent invocation of the Park doctrine in a warning letter to a dietary supplement firm is likely the first time the agency has cited the responsible corporate officer doctrine in a warning letter, according to several food and drug attorneys, who disagreed about whether the move marks a change in the way FDA will enforce supply chain security. One attorney said FDA could be "overstating" its authorities with the letter, which cited a supplement distributor for Good Manufacturing Practice violations by its contract manufacturers, while others saw it as a useful cautionary example for other FDA-regulated industries. 1027 wordse pay to read found here