AR Fabricating in Georgetown was cited 3 times by the Food and Drug Administration (FDA) during an inspection conducted on Feb. 11, as detailed by data available on the FDA’s website.
The inspection addressed the following areas:
- Compliance: Devices
- Postmarket Assurance: Devices
According to the FDA’s website, the company received citations for the following issues:
- ‘Criteria for the evaluation and selection of suppliers were not established.’
- ‘Production controls do not include documentation of procedures and methods for the control of production.’
- ‘Processes for production and service provision where the resulting output cannot be, or is not, verified by subsequent monitoring or measurement were not adequately validated.’
The FDA regularly inspects businesses across the United States to ensure workplaces and products follow relevant FDA standards to protect public health. Results of these inspections are made public.
The FDA’s website states that the agency is chiefly tasked with overseeing the safety and quality of human and animal drugs, biological merchandise, medical devices and tobacco products.
Information for this article comes from the U.S. Food and Drug Administration. The original data can be accessed here.
