A Memphis, Tennessee company has been permanently barred from distributing misbranded drugs and products manufactured under insanitary conditions, according to a federal court order.
Keystone Laboratories, Inc., the company’s owner Melinda Menke, and its operator Elizabeth Jumet were accused of violating the Federal Food, Drug, and Cosmetic Act by distributing hair care and skin care products that were not manufactured, processed, packaged, or held subject to current good manufacturing practices for drugs.
The complaint, filed September 25, 2018, at the request of the U.S. Food and Drug Administration, alleged that FDA inspections of Keystone’s facilities and products revealed numerous problems, including an instance in which the company released a batch of hair products despite test results that suggested contamination by the potentially harmful bacteria Staphylococcus aureus (S. aureus).
Keystone Laboratories, Inc., Melinda Menke, and Elizabeth Jumet have agreed to be bound by a consent decree filed with the complaint in U.S. District Court for the Western District of Tennessee.
The consent decree entered by the court permanently enjoins the defendants from violating the Food, Drug, and Cosmetic Act. As part of the settlement, the defendants may not manufacture or distribute their over-the-counter drug products from any facility owned or operated by the defendants unless they comply with specific remedial measures set forth in the injunction.
The defendants face severe consequences for their actions, including a permanent injunction from violating the Food, Drug, and Cosmetic Act. This means that they will no longer be able to manufacture or distribute their over-the-counter drug products from any facility owned or operated by them unless they comply with specific remedial measures.
The U.S. Food and Drug Administration’s efforts to protect consumers from adulterated and contaminated over-the-counter drugs and products have led to this significant outcome. The Department of Justice’s commitment to ensuring that manufacturers and sellers of over-the-counter drugs follow safety laws that protect consumers has also been a key factor in this case.
Key Facts
- State: Tennessee
- Category: Drug Trafficking|Fraud & Financial Crimes|Violent Crime
- Source: DOJ Press Release â†â€â€
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