On March 19, TG Labs, Inc. in Centennial was issued seven citations by the Food and Drug Administration (FDA) following an inspection focused on Food Composition, Standards, Labeling and Econ, according to information on the FDA’s website.
The FDA outlined the company’s 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.’
Facilities nationwide are regularly inspected by the FDA to ensure that sites and their products comply with regulations intended to support public health. Findings from these inspections are made available to the public.
The FDA states on its website that it is chiefly responsible for overseeing the production and distribution of drugs for humans and animals, biological products, medical devices, and tobacco products to ensure safety and quality.
Information presented here was sourced from the U.S. Food and Drug Administration. The underlying data can be found here.
