Duval Times

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

This is a 33.3% increase over the number of companies cited in the previous year.

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.

All of the companies cited were involved in either Devices or Food and Cosmetics sectors.

Of the companies cited, three should take voluntary actions to correct their managing operations (75%). Additionally, one company had to take regulatory and/or administrative actions (25%).

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
Golden Lab, LLC	Food and Cosmetics	02/21/2023	Records - established specifications
Golden Lab, LLC	Food and Cosmetics	02/21/2023	Tests, examinations - scientifically valid
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
Refine USA, LLC	Devices	08/16/2023	Purchasing controls, Lack of or inadequate procedures
Sawgrass Nutra Labs, LLC	Food and Cosmetics	09/01/2023	Grounds - drainage areas
Sawgrass Nutra Labs, LLC	Food and Cosmetics	09/01/2023	Physical plant - space; equipment, materials
Sawgrass Nutra Labs, LLC	Food and Cosmetics	09/01/2023	Specifications-component purity, strength, composition
Sawgrass Nutra Labs, LLC	Food and Cosmetics	09/01/2023	Component - verify identity, dietary ingredient
Sawgrass Nutra Labs, LLC	Food and Cosmetics	09/01/2023	Batch record - date, each step