Global TV Concepts, Ltd. in Coconut Creek was issued two violations by the Food and Drug Administration (FDA) following a Feb. 9 inspection, based on information available on the FDA’s website.
The inspection reviewed the following topics:
- Compliance: Devices
- Postmarket Assurance: Devices
The FDA’s records detail the violations given to the company:
- ‘A risk-based approach to the control of the appropriate processes needed for the quality management system has not been applied.’
- ‘Criteria for the evaluation and selection of suppliers were not established.’
The FDA regularly inspects facilities around the country to evaluate whether their products and workplaces meet FDA-regulated laws and rules intended to protect public health. The outcomes of these inspections are made publicly available.
The agency’s website describes the FDA as the government body chiefly tasked with 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.
