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Posted August 2, 2012

FDA Warns Two Supplement Makers of Manufacturing Violations

On July 19, 2012, the FDA issued a warning letter to H & L Jerch Sales, Inc. for failing to maintain written quality control procedures, which constitutes a violation of current Good Manufacturing Practices (cGMP) and caused the company’s products to be declared adulterated.

On July 24, 2012, the agency issued a warning letter to United Nutrition Labs, Inc. for failing to comply with cGMPs for proper identity testing of ingredients and calibration of manufacturing and testing equipment. As a result, the FDA declared United Nutrition Labs Inc.’s products to be adulterated.

Both warnings were issued following FDA facility inspections conducted in 2011.

The number of FDA inspections of dietary supplement manufacturing facilities has increased each year since the agency began monitoring company compliance with new industry regulations in 2008. These new regulations were established in 2007 by the FDA’s final rule on Good Manufacturing Practices for the Dietary Supplement Industry. Dietary supplement manufacturers were given between one and three years to comply with the new regulations, depending on the size of the company.