Elucid Bioimaging, Inc., located in Boston, was issued one citation by the Food and Drug Administration (FDA) as part of a March 20 inspection, according to data available on the FDA’s website.
Areas reviewed during the inspection included:
- Compliance: Devices
- Postmarket Assurance: Devices
The FDA report noted the company was cited for the following issue: ‘Procedures for timely complaint handling have not been adequately documented.’
The FDA regularly inspects facilities nationwide to verify compliance with FDA regulations intended to protect public health. These inspection findings are made available to the public.
Information from the agency’s website states the FDA is a federal body tasked with overseeing the safety and quality of human and veterinary drugs, biological items, medical equipment and tobacco products.
Information for this story was sourced from the U.S. Food and Drug Administration. The underlying data is accessible here.
