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Sunday, December 29, 2024

How many companies in cities across Dallas County received FDA citations in 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

There was one company in a city associated with Dallas County that received an FDA citation as a result of one inspection conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous year.

The only citation issued in the county was delivered as 'An investigation was not conducted in accordance with the signed statement of investigator and investigational plan'.

The company cited should take a voluntary action to correct its managing 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 Within Dallas County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Kathleen Jones, Clinical Investigator, M.D.Biologics01/13/2023FD-1572, protocol compliance

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