Naples Standard

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

This is unchanged from the number of companies cited in the previous year.

The citations in the county include:

• You did not establish and follow written procedures for maintaining, cleaning, and sanitizing, equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements.
• Written MDR procedures have not been implemented.
• Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.

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.

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
Arthrex, Inc.	Devices	05/05/2023	Lack of Written MDR Procedures
Arthrex, Inc.	Devices	05/05/2023	Lack of or inadequate complaint procedures
One Planet Nutrition, LLC	Food and Cosmetics	01/26/2023	Specifications - component identity
One Planet Nutrition, LLC	Food and Cosmetics	01/26/2023	Specifications - labels, packaging
One Planet Nutrition, LLC	Food and Cosmetics	01/26/2023	Specifications - identity, purity, strength, composition
One Planet Nutrition, LLC	Food and Cosmetics	01/26/2023	Written procedures - quality control operations
Paradise Supplements & Packaging	Food and Cosmetics	10/11/2023	Procedures - equipment - cleaning, sanitizing