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Thursday, November 21, 2024

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

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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 four companies in a city associated with Durham County, North Carolina, that received four FDA inspections in the third quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 63.6% decrease from the number of companies inspected in the previous quarter, when 11 companies received 11 inspections.

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

There were three companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions. One should take voluntary action to correct its management operations.

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 a City Within Durham County and Their Inspection Results
Company NameArea of BusinessInspection DateResult
Digisonics, Inc.Devices08/12/2024No Action Indicated (NAI)
Indivior Manufacturing, LLCDrugs07/26/2024Voluntary Action Indicated (VAI)
James P. Zidar, M.D.Devices08/07/2024No Action Indicated (NAI)
Rex Hospital, Inc.Biologics09/09/2024No Action Indicated (NAI)

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