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Durham Reporter

Tuesday, November 5, 2024

FDA issued 4 citations in cities across Durham County in Q4 2023

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James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

There were two companies in a city associated with Durham County that received FDA citations as a result of two inspections conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is unchanged from the number of companies cited in the previous quarter.

The citations in the county include:

  • Procedures for identifying product during all stages of receipt, production, distribution, and installation have not been established.
  • Procedures for the control of storage areas and stock rooms have not been established.
  • A device history record has not been maintained.

Both companies cited should take voluntary actions to correct their 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 Durham County Cities and the citations they received in Q4 2023
Company NameArea of BusinessInspection DateIssue Cited
American Red Cross Blood ServicesBiologics10/16/2023Backup data not assured as exact and complete
Avioq, Inc.Biologics12/05/2023Identification procedures, Lack of or inadequate procedures
Avioq, Inc.Biologics12/05/2023Lack of or inadequate procedures for storage.
Avioq, Inc.Biologics12/05/2023DHR - not or inadequately maintained

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