The United States has filed a complaint and the U.S. District Court for the Eastern District of New York has entered a consent decree against Mira Health Ltd. (Mira), its chief operating officer, Michael S. Ragno Sr., and its quality assurance manager, Michael S. Ragno Jr., all of Farmingdale, New York.
Assistant Attorney General Stuart F. Delery of the Justice Department’s Civil Division
and U.S. Attorney Loretta E. Lynch of the Eastern District of New York made the announcement.
The lawsuit alleges that the defendants violated the Federal Food, Drug and Cosmetic Act (FDCA) by manufacturing and distributing dietary supplements that were adulterated. Under the FDCA dietary supplement manufacturers are required have systems in place to ensure that their products meet specifications for identity, purity, strength and composition.
The government’s actions resulted from a series of inspections of Mira’s manufacturing facility, which revealed, among other things, that Mira failed
to ensure that components, dietary supplements, packaging and labels were not mixed-up, contaminated or deteriorated.
In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction that prohibits them from committing violations of the FDCA.
The consent decree
requires the dietary supplement manufacturer to cease all operations
and requires that if the defendants wish to resume manufacturing dietary supplements in the future, the FDA first must determine that Mira’s manufacturing practices have come into compliance with the law.
The consent decree was entered by the court today.
Mira gained national attention in July 2013 when Purity First Health Ltd, a company that sold dietary supplements manufactured by Mira, became the subject of an FDA recall.
Anabolic steroids were found to be present in the Healthy Life Chemistry By Purity B-50 dietary supplement.
At the time of the recall, 29 illnesses and one hospitalization had been documented.
The FDA referred this matter to the Department of Justice. The Consumer Protection Branch of the Justice Department’s Civil Division together with the U.S. Attorney’s Office for the Eastern District of New York filed this case on behalf of the United States.