North OC Times

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

This is an 85.7% decrease from the number of companies cited in the previous month.

The citations in the county were 'Written standard operating procedures including all steps to be followed in the processing and distribution of blood and blood components for allogeneic transfusion were not always established and maintained' and 'Records are not concurrently maintained with the performance of each significant step in the processing of each unit of blood and blood components so that all steps can be clearly traced'.

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.

Company Name	Area of Business	Inspection Date	Issue Cited
Children's Hospital of Orange County	Biologics	01/16/2024	Establish, maintain and follow manufacturing SOPs
Children's Hospital of Orange County	Biologics	01/16/2024	Concurrent documentation