Central Texas News

There was one company in a city associated with Bastrop County that received FDA citations 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 citations in the county include:

• Process validation activities and results have not been adequately documented and adequately approved.
• Procedures for rework of nonconforming product have not been adequately established.
• Corrective and preventive action activities and/or results have not been adequately documented.

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.

Company Name	Area of Business	Inspection Date	Issue Cited
AEI Technologies, Inc.	Devices	01/29/2025	Documentation
AEI Technologies, Inc.	Devices	01/29/2025	Product rework procedures, Lack of or inadequate procedures
AEI Technologies, Inc.	Devices	01/29/2025	Documentation