Houston Republic

There were two companies in a city associated with Fort Bend County that received FDA citations as a result of two inspections conducted in the county over the third quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 75% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

• Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.
• Records do not include the disposition of rejected components, drug product containers and closures.
• You did not develop an FSVP.

Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).

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
Airgas USA, LLC	Drugs	08/15/2024	Records reviewed annually
Airgas USA, LLC	Drugs	08/15/2024	Records of disposition of rejected material
Winfull Corporation	Food and Cosmetics	07/26/2024	Develop FSVP