During a March 3 inspection focused on device compliance, Kimball Electronics – Indianapolis in Indianapolis received one citation from the Food and Drug Administration (FDA), according to data posted on the FDA’s website.
FDA records indicate the company was cited for the following issue: ‘Corrective action procedures defining the requirements for verifying that the corrective action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device and reviewing the effectiveness of corrective action taken have not been adequately documented.’
The FDA regularly inspects facilities nationwide to evaluate whether workplaces and their products follow laws and regulations overseen by the agency, which aim to protect public health. Results from inspections are made publicly accessible.
The FDA states on its website that it serves as a government authority responsible for overseeing the manufacture and distribution of human and animal drugs, biological products, medical devices, and tobacco products to ensure safety and quality.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
