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Chapel Hill Review

Wednesday, December 25, 2024

How many companies in cities in Durham County received FDA inspections in Q3 2023?

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Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

There were 11 companies in cities associated with Durham County, North Carolina, that received 12 FDA inspections in the third quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 31.3% decrease from the number of companies inspected in the previous quarter, when 16 companies received 16 inspections.

Most of the companies inspected at the time were involved in the Food and Cosmetics and Devices sectors. Both the Biologics and Drugs 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 (81.8%). Two should take voluntary action to correct their management operations (18.2%).

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
623 Medical, LLCDevices08/10/2023No Action Indicated (NAI)
Bleep, LLCDevices08/25/2023Voluntary Action Indicated (VAI)
CSL Plasma, Inc.Biologics07/21/2023No Action Indicated (NAI)
Cardinal Health, Inc.Food and Cosmetics09/14/2023No Action Indicated (NAI)
Cristina Gasparetto, M.D.Drugs09/29/2023No Action Indicated (NAI)
GlacierPoint Enterprises - CarolinasFood and Cosmetics07/20/2023Voluntary Action Indicated (VAI)
Jad Walters, Ph. D.Devices09/06/2023No Action Indicated (NAI)
Ladyfingers Catering, LLCFood and Cosmetics08/09/2023No Action Indicated (NAI)
Syneos HealthDrugs07/13/2023No Action Indicated (NAI)
Syneos HealthDrugs08/31/2023No Action Indicated (NAI)
Thomas L. Ortel, M.D.Biologics07/17/2023No Action Indicated (NAI)
Vector Tobacco, LLCTobacco08/09/2023No Action Indicated (NAI)

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