Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Thursday, July 18, 2019
Federal judge enters consent decree against Arkansas food and medical product grocery warehouse for insanitary conditions
The U.S. District Court for the Western District of Arkansas ordered J and L Grocery, LLC. of Alma, Arkansas, the company’s owner, James T. White, and its manager, Lori A. Layne, to stop distributing food, drug products, medical devices and cosmetics until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in a consent decree. According to the amended complaint, J and L Grocery held FDA-regulated products under insanitary conditions in which they may have become contaminated with filth, including widespread insect, rodent and other live animal infestation, in violation of federal law.
“U.S. consumers rely on the oversight and inspection efforts of the FDA to ensure that their foods and medical products are safe. We will not tolerate insanitary conditions at facilities—like J and L Grocery— that serve U.S. consumers. Product safety at all points in the supply chain must be a high priority, and distributors have a critical responsibility to ensure products are kept safe for Americans to consume or use,” said FDA Acting Commissioner Ned Sharpless, M.D. “When adulterated products make their way into the U.S. marketplace, it places consumers at risk. The FDA will continue our vigorous oversight and will take action to prevent the distribution of potentially contaminated products to the American people.”