El Paso Standard

There were five companies in a city associated with El Paso County that received FDA citations as a result of five inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 150% increase over the number of companies cited in the previous year.

Of the 15 citations issued, the most common citations include:

• The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
• Representative samples are not taken of each shipment of each lot of components for testing or examination.

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 the Drugs sector.

All of the 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
CareFusion 213, LLC	Devices	09/29/2023	Procedures not in writing, fully followed
CareFusion 213, LLC	Devices	09/29/2023	Buildings not maintained in good state of repair
CareFusion 213, LLC	Devices	09/29/2023	Representative Samples
CareFusion 213, LLC	Devices	09/29/2023	Component written specification
CareFusion 213, LLC	Devices	09/29/2023	Scientifically sound laboratory controls
CareFusion 213, LLC	Drugs	09/29/2023	Procedures not in writing, fully followed
CareFusion 213, LLC	Drugs	09/29/2023	Buildings not maintained in good state of repair
CareFusion 213, LLC	Drugs	09/29/2023	Representative Samples
CareFusion 213, LLC	Drugs	09/29/2023	Component written specification
CareFusion 213, LLC	Drugs	09/29/2023	Scientifically sound laboratory controls
Hermes Honey, LLC	Food and Cosmetics	01/17/2023	Record - translate to English
Ionetix Corporation	Drugs	09/14/2023	Orderly handling, prevention of mix-ups, prevention of contamination
Ionetix Corporation	Drugs	09/14/2023	Lab sampling and test procedures
Mount Franklin Foods, LLC	Food and Cosmetics	03/02/2023	Supply-chain program - Assurance (Adequate)
Sun View Foods, LLC	Food and Cosmetics	09/01/2023	Identification - entry