During an April 21 inspection, Boscogen, Inc. in Irvine was cited four times by the Food and Drug Administration (FDA) for issues related to Food Composition, Standards, Labeling and Econ, according to data posted on the FDA’s website.
The FDA website shows the following citations were 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 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 routinely inspects facilities nationwide to assess whether work environments and products comply with laws and regulations meant to safeguard overall public health. The results of these inspections are publicly available.
According to its website, the FDA is a federal agency chiefly tasked with overseeing the safety and quality of human and animal drugs, biological items, 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.
