During a March 19 inspection, TG Labs, Inc. in Centennial received seven citations from the Food and Drug Administration (FDA) over Food Composition, Standards, Labeling and Econ, FDA data show.
The FDA records list the citations as follows:
- ‘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, purity, strength and composition.’
- ‘You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.’
- ‘You did not ensure that the tests or examinations that you used to determine whether the specifications are met are appropriate, scientifically valid methods.’
- ‘Your master manufacturing record did not include all required information.’
- ‘Your batch production record did not include all required information.’
- ‘You did not verify that the laboratory examination and testing methodologies are appropriate for their intended use.’
The FDA conducts regular inspections nationwide to check workplace and product compliance with agency laws and regulations, which are designed to advance public health. The outcomes of these inspections are made available to the public.
FDA’s website states the agency’s primary responsibilities include 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.
