FDAnews Drug Daily Bulletin

Supplement Company Draws Warning Over GMPs

June 1, 2017

A Utah supplement company drew a warning from the FDA for failing to comply with GMP requirements.

The Thor facility in Ogden lacked specifications for quality control in its supplement manufacturing or packaging operations, the agency said. Inspectors found the facility had no master manufacturing records for each formulation or for each batch size.

The company also lacked written procedures and records for training and qualifying employees on manufacturing, packaging and labeling processes and for how they handled complaints, according to the warning letter.

Investigators also reviewed the company’s website, and found unapproved claims that the products were intended for use in the cure, mitigation, treatment, or prevention of disease.

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