During a March 3 inspection focused on device compliance, the Food and Drug Administration (FDA) issued 1 citation to Kimball Electronics – Indianapolis in Indianapolis, FDA data show.
The citation addressed 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 conducts inspections nationwide to assess whether workplaces and products adhere to regulations designed to promote public health, disclosing results after completion.
As stated on its website, the FDA is a federal agency tasked with overseeing the safety and quality of human and animal drugs, biological products, medical devices and tobacco products.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
