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Thursday, November 21, 2024

How many companies were inspected by the FDA in cities located in Durham County in Q2 2023?

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Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

There were 16 companies in cities associated with Durham County, North Carolina, that received 16 FDA inspections in the second quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 33.3% increase over the number of companies inspected in the previous quarter, when 12 companies received 12 inspections.

Most of the companies inspected at the time were involved in the Devices and Food and Cosmetics sectors. The second most common type of company inspected worked in the Drugs sector.

There were 11 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (68.8%). Five should take voluntary action to correct their management operations (31.3%).

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
AmerisourceBergen Drug CorporationFood and Cosmetics06/15/2023Voluntary Action Indicated (VAI)
Blood Connection, Inc.Biologics06/23/2023No Action Indicated (NAI)
Carolina Conceptions, PABiologics06/01/2023Voluntary Action Indicated (VAI)
CivaTech Oncology, Inc.Devices06/14/2023Voluntary Action Indicated (VAI)
Clear Choice Therapeutics, Inc.Devices05/11/2023Voluntary Action Indicated (VAI)
Deep Blue Medical Advances, Inc.Devices05/18/2023No Action Indicated (NAI)
Epiphany Craft MaltFood and Cosmetics05/16/2023No Action Indicated (NAI)
IQVIA BiotechDrugs04/27/2023No Action Indicated (NAI)
Merz North America, Inc.Devices06/22/2023No Action Indicated (NAI)
North Carolina State University Dairy PlantFood and Cosmetics06/29/2023No Action Indicated (NAI)
Novan, Inc.Drugs06/07/2023No Action Indicated (NAI)
Premier Research and ConsultingDrugs05/17/2023No Action Indicated (NAI)
R & H Produce, Inc.Food and Cosmetics05/17/2023No Action Indicated (NAI)
The ICEE CompanyFood and Cosmetics04/04/2023No Action Indicated (NAI)
UPS Supply Chain Solutions, Inc.Drugs06/29/2023No Action Indicated (NAI)
restor3d, Inc.Devices05/12/2023Voluntary Action Indicated (VAI)

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