City of Industry dietary supplement maker to close after FDA probe
A Los Angeles area pharmaceuticals manufacturer has agreed to close its operations and to recall and destroy all the dietary supplements it has sold since 2011 as part of an agreement with federal regulators.
Health One Pharmaceuticals Inc. distributed unapproved supplements that claimed to treat diabetes, allergies and cancer, according to a lawsuit filed by the Department of Justice and the Food and Drug Administration seeking to shut down the company.
The City of Industry company also violated federal regulations when it didn’t test the ingredients it used in supplements to verify their identity and did not properly label ingredients, according to the lawsuit filed last month.
Owner Richard S. Yeh agreed Thursday to close the company and destroy its supplements under FDA supervision. The company can only reopen with approval from the FDA and an independent auditor.
The FDA found several violations of federal guidelines during inspections of the company’s facility in March 2014 as well as in April and May 2013.
The FDA inspectors first noted violations at the company’s facilities in 2011. The company did not follow through on written promises to meet federal regulations, according to the lawsuit.
For example, inspectors found a “cancer support formula” product that did not list all the ingredients in the product or the name and address of the manufacturer.
The company also failed to test dietary supplements to verify that finished batches met specifications required by law, according to the lawsuit.
The company manufactured its products using ingredients imported from outside California, including China and Singapore, and distributed its products around the country, the complaint said.
“We have an unwavering commitment to ensuring that the dietary supplements in this country are safe and have been manufactured in accordance with federal law,” acting Assistant Atty. Gen. Joyce R. Branda for the Justice Department’s Civil Division said in a statement.
The consent decree and the suit did not disclose the size of the recall.
Yeh could not be reached for comment Friday.
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