Thursday, September 19, 2019

Thursday, September 19, 2019

U.S. FOOD AND DRUG ADMINISTRATION: Federal judge enters consent decree against Arkansas food and medical product grocery warehouse for insanitary conditions


U.S. Food and Drug Administration issued the following announcement on July 18.

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.”

During the FDA’s inspection of J and L Grocery in September-October 2018, investigators observed multiple live and dead rodents, rodent nesting, live racoons, live cats, a dead possum, animal feces and urine-stained products in and around the company’s seven warehouses and sheds used to store food, medical products and cosmetics. The FDA issued two Administrative Detention Orders at J and L Grocery, dated October 9 and 19, 2018. On November 7 and 8, 2018, the U.S. Marshals Service conducted a mass seizure of the company’s FDA-regulated human and animal food products, over-the-counter (OTC) drugs, cosmetic products and medical devices.

The consent decree of condemnation and permanent injunction entered by U.S. District Judge P.K. Holmes, III requires J and L Grocery to cease distribution of FDA-regulated products until it completes corrective actions. Under the consent decree, J and L Grocery may not resume operations until it establishes and implements a comprehensive written sanitation control program and receives written authorization from the FDA that it appears to be in compliance with the FD&C Act, among other requirements. As part of the consent decree, the company agreed to destroy the seized products.

The U.S. Department of Justice filed the complaint on behalf of the FDA.

Original source can be found here.

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