GTX Technologies in Amarillo was issued eight citations by the Food and Drug Administration during a Jan. 29 inspection, FDA records show.
The inspection addressed these focus areas:
- Food Composition, Standards, Labeling and Econ
- Foodborne Biological Hazards
The FDA records detail the following citations given 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 personnel did not ensure that required reserve samples were collected and held.’
- ‘You do not have quality control operations for a material review and disposition decision.’
- ‘You did not establish written procedures for when a returned dietary supplement is received, when a returned dietary supplement must be destroyed, or otherwise suitably disposed, when a returned dietary supplement may be salvaged, for conducting an investigation of your manufacturing processes and other batches for a returned dietary supplement and quality control personnel to approve a returned dietary supplement for reprocessing.’
- ‘You did not establish written procedures for the requirements to review and investigate a product complaint.’
- ‘You did not have appropriate quality control operations to ensure that food is suitable for human consumption.’
- ‘You did not inspect, segregate or otherwise handle raw materials and other ingredients to ensure they were clean and suitable for processing.’
The FDA conducts routine inspections of facilities nationwide to evaluate compliance with safety standards outlined in FDA-regulated laws. Findings from these inspections are posted online.
As stated on its website, the FDA serves as a federal agency that oversees the safety and quality of human and animal drugs, biological products, medical supplies and tobacco for public health purposes.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
