There was one company in a city associated with Collier County that received FDA citations as a result of one inspection conducted in the county over the first quarter of 2025, according to reports from the U.S. Food and Drug Administration (FDA).
This is an increase over the number of companies cited in the previous quarter.
The citations in the county were ‘Written MDR procedures have not been implemented’ and ‘Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established’.
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.
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 |
|---|---|---|---|
| Arthrex, Inc. | Devices | 01/13/2025 | Lack of Written MDR Procedures |
| Arthrex, Inc. | Devices | 01/13/2025 | Lack of or inadequate complaint procedures |
