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Maryland State Wire

Friday, May 3, 2024

FDA conducted third highest number of inspections on device companies in Maryland during 2023

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Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

In 2023, 12 device companies received 12 FDA inspections in Maryland, according to the U.S. Food and Drug Administration (FDA).

This was the third highest number of inspections per type of company made by the FDA in Maryland, equalling 7.7% of all inspections in 2023.

Of all the Maryland companies involved in the device sector, Healthy Spirit, LLC received the most citations from the FDA in 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.

Top 10 FDA Inspections by Number of Actions Indicated in Maryland During 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring243--
Blood and Blood Products31--
Compliance: Devices25--
Drug Quality Assurance151
Food Composition, Standards, Labeling and Econ233--
Foodborne Biological Hazards62312
Human Cellular, Tissue, and Gene Therapies2----
Monitoring of Marketed Animal Drugs, Feed, and Devices631
Postmarket Assurance: Devices5----
Technical Assistance: Food and Cosmetics73--

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