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Saturday, November 2, 2024

FDA Inspection: What type of North Carolina companies were under most scrutiny during Q2 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 the second quarter of 2023, 42 Food and Cosmetics companies received 42 FDA inspections in North Carolina, according to the U.S. Food and Drug Administration (FDA).

This was the highest number of inspections per type of company made by the FDA in North Carolina, equalling 56.8% of all inspections in the second quarter of 2023.

Of all the North Carolina companies involved in the Food and Cosmetics sector, Yamco, LLC, Blackburn Brothers Seafood, Inc., and AmerisourceBergen Drug Corporation received the most citations from the FDA in the second quarter of 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 North Carolina During Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring8----
Blood and Blood Products10----
Compliance: Devices25--
Drug Quality Assurance11--
Food Composition, Standards, Labeling and Econ92--
Foodborne Biological Hazards347--
Human Cellular, Tissue, and Gene Therapies53--
Postmarket Assurance: Devices43--
Technical Assistance: Food and Cosmetics3----
Tobacco Post-Market Activities2----

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