FDA Wins Permanent Injunction in Salmonella Case
The decree and injunction resolve the seizure action and prohibit further use of the seized product unless specifically approved by the FDA; it also permanently enjoins the defendants from manufacturing milk powder products at their facility unless they comply with certain remedial provisions.
A U.S. District Court judge in Virginia has entered a consent decree of condemnation and permanent injunction against Valley Milk Products LLC, Michael W. Curtis, Robert D. Schroeder, and Jennifer J. Funkhouser, ordering the condemnation of certain seized milk powder products and preventing further distribution of adulterated milk powder products, the Department of Justice announced March 15. DOJ filed a seizure action last November at the request of the U.S. Food and Drug Administration, which alleged certain milk powder products of the defendants were manufactured under insanitary conditions and may have been rendered injurious to health. The complaint sought to seize and condemn certain adulterated milk powder products at Valley Milk Products' Strasburg, Va., facility.
The decree and injunction resolve the seizure action and prohibit further use of the seized product unless specifically approved by the FDA; it also permanently enjoins the defendants from manufacturing milk powder products at their facility unless they comply with certain remedial provisions.
"The Food, Drug, and Cosmetic Act is designed to bolster public confidence in food safety by protecting consumers from unsafe food, including food produced under visibly insanitary conditions," said Acting Assistant Attorney General Chad A. Readler of DOJ's Civil Division. "The Department of Justice will continue to work cooperatively with the FDA to ensure that food facilities employ proper precautions, so that our food is safe for consumption."
Valley Milk Products LLC manufactures Grade A and non-Grade A milk products, including milk powder products, condensed milk products, and butter. The permanent injunction named Valley Milks' General Manager Michael W. Curtis, Plant Manager Robert D. Schroeder, and Quality Control Compliance Officer Jennifer J. Funkhouser.
"As alleged in the complaint, during a 2016 inspection of Valley Milk, FDA confirmed the presence of Salmonella meleagridis in the Strasburg facility," DOJ's news release stated. "Salmonella strains were nearly identical to Salmonella strains found at the firm in 2010, 2011, and 2013. In addition, the complaint alleged that Salmonella meleagridis was also present in the firm’s undistributed finished product samples. The complaint also alleges that, in addition to the presence of Salmonella, the defendants’ milk processing facility had insanitary conditions, including dripping brown fluids and old product residue within the processing equipment. The complaint alleges that this evidence demonstrates that the firm’s sanitation practices were inadequate to control or eliminate Salmonella meleagridis in their processing environment. The seized milk powder products have been condemned and forfeited to the United States. Under the provisions of the consent decree entered by the Court, Valley Milk may attempt to bring the condemned products into compliance with the Federal Food, Drug, and Cosmetic Act under the supervision of the FDA. Valley Milk is prohibited from disposing of any part of the condemned food until FDA determines that the food has been safely reconditioned. If the food cannot be reconditioned, it will be destroyed by a method approved by FDA."
If the defendants want to resume manufacturing milk powder products at the Strasburg facility, they must notify FDA in advance and comply with certain remedial provisions in the decree, which requires that they create and implement a written sanitation control program.
DOJ said this action does not affect Valley Milk's liquid milk products.