Durham Reporter

There were two companies in a city associated with Orange 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 a 100% increase over 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.

Company Name	Area of Business	Inspection Date	Issue Cited
American Red Cross Blood Services	Biologics	10/16/2023	Backup data not assured as exact and complete
Avioq, Inc.	Biologics	12/05/2023	Identification procedures, Lack of or inadequate procedures
Avioq, Inc.	Biologics	12/05/2023	Lack of or inadequate procedures for storage.
Avioq, Inc.	Biologics	12/05/2023	DHR - not or inadequately maintained