Artemis Nutritionals, LLC. in Ogden received five citations from the Food and Drug Administration during a March 16 inspection addressing Food Composition, Standards, Labeling and Econ, according to data posted by the FDA.
FDA records detail the following citations issued to the company:
- ‘For component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary supplement are met and limits on contamination to ensure the quality of the dietary supplement.’
- ‘You did not establish product specifications for identity, purity, strength, composition and limits on contamination.’
- ‘Your quality control operations did not include reviewing and approving master manufacturing records.’
- ‘Your master manufacturing record did not include all required information.’
- ‘Your batch production record did not include all required information.’
The FDA regularly inspects facilities nationwide to confirm that workplaces and their products comply with federal laws and regulations designed to protect public health. Results of these inspections are made publicly available.
The agency’s website states the FDA is responsible for overseeing the safety and quality of drugs, biological products, medical supplies and tobacco products for humans and animals.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
