District Court Enters Permanent Injunction Against Virginia Company and Employees to Prevent Distribution of Adulterated Milk Powder Products
The U.S. District Court for the Western District of Virginia entered a consent decree of condemnation and permanent injunction against Valley Milk Products LLC, Michael W. Curtis, Robert D. Schroeder, and Jennifer J. Funkhouser (defendants), the Department of Justice announced today. The consent decree also orders the condemnation of certain seized milk powder products and prevents the further distribution of adulterated milk powder products.
The Department filed a seizure action in the Western District of Virginia on Nov. 18, 2016, at the request of the U.S. Food and Drug Administration (FDA). The November complaint alleged that certain milk powder products of the defendants were manufactured under insanitary conditions whereby they may have become contaminated with filth, and/or whereby they may have been rendered injurious to health. That complaint sought to seize and condemn certain adulterated milk powder products at Valley Milk Products’ Strasburg, Virginia facility.
Yesterday’s filing resolves that seizure action and prohibits further use of the seized product unless specifically approved by the FDA, and additionally permanently enjoins the defendants from manufacturing milk powder products at their facility, absent compliance with certain specified 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 the Justice Department’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 is a manufacturer of Grade A and non-Grade A milk products including, but not limited to milk powder products, condensed milk products, and butter. The permanent injunction also 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. 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.
The defendants have also agreed to be bound by a permanent injunction that prohibits them from resuming the manufacture of milk powder products at the Strasburg facility without implementing effective corrective action. If the defendants wish to resume manufacturing milk powder products at their Strasburg facility, the defendants must notify FDA in advance, and comply with certain remedial provisions set forth in the Decree. Among other things, the remedial provisions require that the defendants establish and implement a written sanitation control program, which shall set out the details for sanitation control over the manufacturing and storage processes for the facilities used to receive, manufacture, prepare, pack, hold, or distribute milk powder products, and all food handling and storage equipment therein. This action does not affect Valley Milk’s liquid milk products.
The government is represented by Trial Attorney Mary M. Englehart of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Joseph W.H. Mott of the U.S. Attorney’s Office for the Western District of Virginia, with the assistance of Associate Chief Counsel for Litigation Barbara J. Alkalay of the FDA, Office of General Counsel, Department of Health and Human Services.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for Western District of Virginia, visit its website at https://www.justice.gov/usao-wdva.