January 16, 2015 — A California supplement-maker must recall all of its products after a federal court found that it put consumers at risk by failing to follow good manufacturing practices.
The FDA announced that Health One Pharmaceuticals, Inc., has been ordered to destroy — under supervision — all products that were created or distributed between September 1, 2011 and January 15, 2015.
The FDA issued a Warning Letter in March 2012 after finding serious violations of federal manufacturing laws, including:
- Failure to perform tests to verify the identity of dietary ingredients used to manufacture the supplements
- Failure to establish appropriate manufacturing controls
- Failure to maintain, clean and sanitize equipment
Health One assured the FDA they would fix the problems, but follow-up inspections showed that it failed to do so. The FDA also found that some products had labels that did not include common names of all the ingredients.
U.S. 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.
Before Health One can resume operations, they must hire an independent expert to check compliance with manufacturing laws. They must get approval from the FDA to start manufacturing and document compliance for the next five years.
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