Federal Court Shuts Down Supplement Manufacturer

A California drug manufacturer must recall and destroy all of its dietary supplements after a federal court determined that it failed to follow FDA manufacturing practice regulations.

“When a company puts consumers at risk, the FDA will take action to protect public health,” said Melinda K. Plaisier, FDA associate commissioner for regulatory affairs, in a press release. “Our goal is to ensure that consumers have access to dietary supplements that meet federal standards for safety and quality.”

In a warning letter issued to Health One Pharmaceuticals, Inc, on March 28, 2012, the FDA outlined serious violations of current good manufacturing practice (cGMP) requirements, including 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.

Despite assurances from the firm that it was correcting those violations, follow-up inspections showed that it failed to do so, making its products adulterated under the Federal Food, Drug, and Cosmetic Act. Additionally, 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, according to the complaint filed with the federal court.

US District Judge Beverly Reid O’Connell of the Central District of California signed a consent decree of permanent injunction against Health One Pharmaceuticals and its president and owner, Richard S. Yeh. Under FDA supervision, the company must now recall and destroy all dietary supplements that were manufactured, prepared, packed, labeled, held, or distributed between September 1, 2011, and January 15, 2015.

In order to resume operations, the manufacturer needs to receive permission from the FDA and hire an independent expert to assess whether it is in compliance with cGMP requirements. Audit reports documenting compliance with FDA manufacturing regulations then need to be filed with the agency on a biannual basis for at least 5 years.