FDA issues 5 citations to Simplified Supplement Solutions after Salt Lake City inspection

Sara Brenner, Principal Deputy Commissioner at FDA
Sara Brenner, Principal Deputy Commissioner at FDA
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The Food and Drug Administration issued five citations to Simplified Supplement Solutions in Salt Lake City following a March 5 inspection that addressed Food Composition, Standards, Labeling and Econ, according to data posted on the FDA’s website.

The company’s citations included the following, based on the FDA website:

  • ‘For component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications and necessary specifications to ensure the specifications for purity, strength, and composition of the dietary supplement are met.’
  • ‘You did not establish product specifications for identity.’
  • ‘You did not verify that your finished batch of dietary supplement meets product specifications for identity and strength.’
  • ‘You did not follow a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured.’
  • ‘Your batch production record did not include all required information.’

The FDA conducts regular inspections of facilities throughout the U.S. to ensure workplaces and their products comply with federal law and regulations designed to promote public health. Inspection findings are released by the agency to the public.

The FDA states on its website that it serves as the federal agency overseeing the safety and quality of human and animal drugs, biological products, medical supplies and tobacco products.

Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.



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