FDA issued 19 citations in cities across Oklahoma County in 2024

Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA - Official Website
Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA - Official Website
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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.

Companies Located Within Oklahoma County Cities and the Citations They Received in 2024
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


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