Dallas City Wire

There were two companies in cities associated with Collin County that received FDA citations as a result of two inspections conducted in the county in February, according to reports from the U.S. Food and Drug Administration (FDA).

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

The citations in the county include:

• Written standard operating procedures including all steps to be followed in the storage of blood and blood components for further manufacturing purposes were not always followed.
• You did not establish and maintain procedures for testing of HCT/P donors.
• HCT/P donors were not determined to be eligible based on the results of donor screening and testing.

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
Alfred J. Rodriguez, P. A., M.D.	Biologics	02/27/2024	Testing, screening, donor eligibility procedures
Alfred J. Rodriguez, P. A., M.D.	Biologics	02/27/2024	Determination based on screening and testing
Alfred J. Rodriguez, P. A., M.D.	Biologics	02/27/2024	Responsible person to determine, document
CSL Plasma, Inc.	Biologics	02/01/2024	Establish, maintain and follow manufacturing SOPs