Duval Times

There was one company in a city associated with Duval County that received FDA citations as a result of one inspection conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 50% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

• Written MDR procedures have not been developed.
• Procedures for management review have not been established.
• Procedures for quality audits have not been established.

The company cited was involved in the Devices sector.

The company cited should take a voluntary action to correct its 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
Oxygen Therapy Institute	Devices	11/17/2023	Lack of Written MDR Procedures
Oxygen Therapy Institute	Devices	11/17/2023	Management review - Lack of or inadequate procedures
Oxygen Therapy Institute	Devices	11/17/2023	Quality audits - Lack of or inadequate procedures
Oxygen Therapy Institute	Devices	11/17/2023	Training - Lack of or inadequate procedures
Oxygen Therapy Institute	Devices	11/17/2023	Document review, approval documentation
Oxygen Therapy Institute	Devices	11/17/2023	Purchasing controls, Lack of or inadequate procedures
Oxygen Therapy Institute	Devices	11/17/2023	Process control procedures, Lack of or inadequate procedures
Oxygen Therapy Institute	Devices	11/17/2023	Lack of or inadequate procedures - Acceptance activities
Oxygen Therapy Institute	Devices	11/17/2023	Nonconforming product, Lack of or inadequate procedures
Oxygen Therapy Institute	Devices	11/17/2023	Lack of or inadequate procedures
Oxygen Therapy Institute	Devices	11/17/2023	Lack of or inadequate DHR procedures
Oxygen Therapy Institute	Devices	11/17/2023	Lack of or inadequate complaint procedures