A dietary supplement manufacturer has been ordered to stop selling its products after failing to follow manufacturing practice regulations.
U.S. District Judge Beverly Reid O'Connell signed a consent decree of permanent injunction against Health One Pharmaceuticals, Inc., a private label and contract manufacturer of dietary supplements, and its president and owner, Richard S. Yeh, on January 15, 2015.
This followed a warning letter that was sent to the company by the U.S. Food and Drug Administration (FDA) in March 2012, detailing serious violations of current good manufacturing practice (cGMP) requirements. According to the letter, these violations included failure to perform tests to verify the identity of dietary ingredients used to manufacture the supplements; failure to establish appropriate manufacturing controls; and failure to maintain, clean and sanitize equipment.
Subsequent inspections by FDA officials revealed that the California-based company had failed to correct all of the manufacturing violations outlined in the letter. The agency said that failure to follow cGMP requirements meant that the firm's products were classed as adulterated under the Federal Food, Drug, and Cosmetic Act.
The complaint filed with the court also said that certain dietary supplements manufactured by Health One Pharmaceuticals were not properly labeled because the labels did not list the common or usual names of all product ingredients.
The consent decree requires Health One Pharmaceuticals, under FDA supervision, to recall and destroy all dietary supplements that were manufactured, prepared, packed, labeled, held or distributed by the company between September 1, 2011, and January 15, 2015.
Health One Pharmaceuticals and Richard S. Yeh told the court that they have already ceased manufacturing and distributing all food, drugs and dietary supplements.
Before the company is allowed to resume operations, it will need to hire an independent expert to assess whether the firm is in compliance with cGMP requirements. Additionally, for at least the next five years, the company will have to file regular audit reports with the FDA to document its compliance with manufacturing regulations.