FDA inspects Burton Medical in Addison, issues 1 citation Feb. 20
The Food and Drug Administration (FDA) issued one citation to Burton Medical in Addison following an inspection on Feb. 20, according to information published on the FDA's website.
Inspectors reviewed the following areas:
- Compliance: Devices
- Postmarket Assurance: Devices
FDA records indicate the company was cited because: 'The information required by the Global Unique Device Identification Database for each medical device version or model required to bear a unique device identifier (UDI) was not provided.'
The FDA conducts routine inspections at facilities nationwide to ensure products and workplaces comply with FDA-regulated laws and rules meant to safeguard public health. The results are made publicly available.
The agency's website states that the FDA is chiefly tasked with overseeing the safety and quality of human and animal drugs, biological products, medical devices and tobacco products.
Information for this article was sourced from the U.S. Food and Drug Administration. Source data can be found here.