There were three companies in cities associated with Oklahoma County that received FDA citations as a result of three inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 70% decrease from the number of companies cited in the previous year.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not fully followed.
- Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
- There is a lack of written procedures providing cleaning schedules and describing in sufficient detail the methods, equipment and materials to be used for sanitation.
Most of the companies cited were involved in the Food and Cosmetics 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.
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 |
|---|---|---|---|
| Cao Nguyen, Inc. | Food and Cosmetics | 04/16/2024 | Approved supplier procedures – importer established |
| Qualgen, LLC | Drugs | 03/19/2024 | Procedures not in writing, fully followed |
| Qualgen, LLC | Drugs | 03/19/2024 | Training , Education , Experience overall |
| Qualgen, LLC | Drugs | 03/19/2024 | Written sanitation procedures lacking |
| Qualgen, LLC | Drugs | 03/19/2024 | Buildings not maintained in good state of repair |
| Qualgen, LLC | Drugs | 03/19/2024 | Cleaning / Sanitizing / Maintenance |
| Qualgen, LLC | Drugs | 03/19/2024 | Calibration/Inspection/Checking not done |
| Qualgen, LLC | Drugs | 03/19/2024 | Absence of Written Procedures |
| Qualgen, LLC | Drugs | 03/19/2024 | Procedures for sterile drug products |
| Qualgen, LLC | Drugs | 03/19/2024 | Validation lacking for sterile drug products |
| Qualgen, LLC | Drugs | 03/19/2024 | Procedures Written and Followed |
| Qualgen, LLC | Drugs | 03/19/2024 | Description of containers, labels, et. al. |
| Qualgen, LLC | Drugs | 03/19/2024 | Labeling Control Records and Label Copies |
| Qualgen, LLC | Drugs | 03/19/2024 | Investigations of discrepancies, failures |
| Qualgen, LLC | Drugs | 03/19/2024 | Procedures to be written and followed |
| Ultra Botanica, LLC | Food and Cosmetics | 01/19/2024 | Component – qualify supplier |
| Ultra Botanica, LLC | Food and Cosmetics | 01/19/2024 | Specifications met – test, examinations; compliance |
| Ultra Botanica, LLC | Food and Cosmetics | 01/19/2024 | Manufacturing operations – prevent contamination |
| Ultra Botanica, LLC | Food and Cosmetics | 01/19/2024 | Quality control production, process control; material review, disposition |




