January 16, 2015 — The U.S. Food and Drug Administration (FDA) has announced that a federal judge has signed a decree ordering Health One Pharmaceuticals, a Californian dietary supplement-maker, to recall and destroy all of their products due to ongoing violations of good manufacturing requirements.
Problems for Health One began back in March 2012, when the FDA issued a Warning Letter about violations of current Good Manufacturing Practices (cGMP) regulations. The violations put consumer safety at risk.
Inspectors documented the following serious problems:
- 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
Two years later, follow-up inspections found that Health One failed to fix any of the problems outlined in the letter. In addition, inspectors found that some product labels did not include common names of all the ingredients in the product.
Consequently, U.S. District Judge Beverly Reid O’Connell of the Central District of California has signed a consent decree of permanent injunction against Richard S. Yeh, the president and owner.
Health One cannot start making supplements unless they hire an independent expert to ensure compliance with cGMP requirements, gain approval from the FDA, and submit documents proving compliance for the next five years.
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