The Food and Drug Administration (FDA) issued four citations to Boscogen, Inc. in Irvine following an April 21 inspection for Food Composition, Standards, Labeling and Econ, according to data posted on the FDA’s website.
The FDA website shows the company was cited for the following:
- ‘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 and composition.’
- ‘Your quality control personnel approved and released for distribution a batch of dietary supplement that did not meet established product specifications.’
- ‘Your quality control operations for labeling did not include conducting a material review and making a required disposition decision.’
The FDA conducts inspections at facilities nationwide to make sure workplaces and their products meet FDA law and regulation standards set to protect public health. Results from inspections are released to the public.
According to its website, the FDA is a federal agency in charge of 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.
