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Maryland State Wire

Tuesday, April 30, 2024

Maryland: Devices companies were the second most FDA inspected companies in Maryland in December 2023

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

In December 2023, two Devices companies received two FDA inspections in Maryland, according to the U.S. Food and Drug Administration (FDA).

This was the second highest number of inspections per type of company made by the FDA in Maryland, equalling 28.6% of all inspections in December 2023.

Of all the Maryland companies involved in Devices, Shikani Medical, LLC received the most citations from the FDA in December 2023.

The FDA routinely inspects facilities across the nation to determine if the workplaces and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly for businesses to consistently make smarter business decisions for the future.

The FDA is a government agency primarily responsible for monitoring the manufacturing and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

FDA inspections in Maryland during December 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Compliance: Devices--2--
Food Composition, Standards, Labeling and Econ1----
Foodborne Biological Hazards31--
Postmarket Assurance: Devices2----

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