How many companies in cities across Collin County received FDA citations in 2024?

There were 34 companies in cities associated with Collin County that received FDA citations as a result of 35 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 2.9% decrease from the number of companies cited in the previous year.

Of the 97 citations issued, the most common citations include:

• A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
• Your hazard analysis did not identify a hazard that required a preventive control.
• The IRB has no written procedure for conducting its initial review of research.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the Biologics sector.

Of the companies cited, 32 should take voluntary actions to correct their managing operations (94.1%). Additionally, two companies had to take regulatory and/or administrative actions (5.9%).

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.