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Monday, April 29, 2024

How many companies in cities in Durham County received FDA inspections in Q1 2023?

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Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

There were 12 companies in cities associated with Durham County, North Carolina, that received 12 FDA inspections in the first quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 20% increase over the number of companies inspected in the previous quarter, when 10 companies received 10 inspections.

Most of the companies inspected at the time were involved in the Drugs sector. Both the Food and Cosmetics and Devices sectors sectors tied for second most common type.

There were nine companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (75%). Three should take voluntary action to correct their management operations (25%).

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

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

Companies Located in Cities Within Durham County and Their Inspection Results
Company NameArea of BusinessInspection DateResult
Ablexan CorporationDevices01/23/2023No Action Indicated (NAI)
Alcami Carolinas CorporationDrugs03/13/2023Voluntary Action Indicated (VAI)
Allison K. Ross, M.D.Drugs02/16/2023No Action Indicated (NAI)
Atlantic Fertility Center Partners, LLCBiologics01/11/2023No Action Indicated (NAI)
Durham Exchange Club Industries, Inc.Tobacco02/21/2023No Action Indicated (NAI)
Edward C. Smith, M.D.Drugs03/17/2023No Action Indicated (NAI)
Lalilab, Inc.Food and Cosmetics03/27/2023No Action Indicated (NAI)
Luminelle, Inc.Devices02/21/2023Voluntary Action Indicated (VAI)
SpringWorks Therapeutics, Inc.Drugs03/31/2023Voluntary Action Indicated (VAI)
Syneos HealthDrugs02/02/2023No Action Indicated (NAI)
UCB Biosciences, Inc.Drugs03/24/2023No Action Indicated (NAI)
Wards Fruit & Produce CompanyFood and Cosmetics01/10/2023No Action Indicated (NAI)

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