US dietary supplement manufacturer Health One Pharmaceuticals ordered to halt sales

US dietary supplement manufacturer  Health One Pharmaceuticals ordered to halt sales

A federal judge has ordered California-based dietary supplement manufacturer Health One Pharmaceuticals to stop selling its products.

The company was found to be non-compliant with regulations outlined by the Food and Drug Administration (FDA).

Violations included failure to perform tests to verify the identity of ingredients used in supplements, failure to establish appropriate manufacturing controls and failure to maintain, clean and sanitize equipment.

Health One Pharmaceuticals was issued a warning letter in 2012 listing violations, but the FDA performed a follow-up inspection and found that the company had failed to address problems. All products that were manufactured, prepared packed, labelled, held, or distributed between September 1, 2011, and January 15, 2015 will be recalled and destroyed.

In order to resume operations, Health One Pharmaceuticals will need to apply for permission from the FDA and hire an independent expert to assess whether it is compliant with requirements. Audit reports will need to filed with the FDA biannually for at least five years.

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