Elucid Bioimaging, Inc., based in Boston, was issued 1 citation by the Food and Drug Administration (FDA) during a March 20 inspection, according to data from the FDA’s website.
The agency’s inspection focused on these areas:
- Compliance: Devices
- Postmarket Assurance: Devices
FDA records indicate the citation was given for this reason: ‘Procedures for timely complaint handling have not been adequately documented.’
The FDA regularly inspects facilities nationwide to assess if operations and products comply with FDA regulations intended to strengthen public health. These inspection outcomes are made available to the public.
The FDA’s website explains that it is a government body charged with overseeing the safety and quality of human and animal pharmaceuticals, biological items, medical supplies and tobacco products.
Information for this story was sourced from the U.S. Food and Drug Administration. Source data is available here.
