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Durham Reporter

Tuesday, April 22, 2025

How many companies in cities across Orange County received FDA citations in Q1?

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Vid Desai FDA’s Chief Information Officer | Official Website

Vid Desai FDA’s Chief Information Officer | Official Website

There was one company in a city associated with Orange County that received an FDA citation as a result of one inspection conducted in the county over the first quarter of 2025, 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 quarter.

The only citation issued in the county was delivered as 'Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA'.

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.

According to its website, 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.

Companies located within Orange County Cities and the citations they received in Q1
Company NameArea of BusinessInspection DateIssue Cited
United Therapeutics CorporationDrugs02/28/2025Systems in place to comply with verifciation requirements

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