There were four companies in a city associated with Collier County that received FDA citations as a result of four inspections conducted in the county in 2025, according to 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 implemented.
- Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
- Failure to maintain storage and distribution records.
Most of the companies cited were involved in the Devices sector.
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.
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 and 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 |
| Daane Labs | Drugs | 09/19/2025 | Procedures not in writing, fully followed |
| Daane Labs | Drugs | 09/19/2025 | Scientifically sound laboratory controls |
| Daane Labs | Drugs | 09/19/2025 | Written record of investigation incomplete |
| Daane Labs | Drugs | 09/19/2025 | Comparison of Test Results to Specifications |
| NCH Baker Hospital Downtown | Biologics | 07/10/2025 | Required records |
| Pharmacaribe, LLC | Devices | 08/20/2025 | Lack of or inadequate organizational structure |
| Pharmacaribe, LLC | Devices | 08/20/2025 | Management review dates |
| Pharmacaribe, LLC | Devices | 08/20/2025 | Quality Audit/Reaudit – conducted |
| Pharmacaribe, LLC | Devices | 08/20/2025 | Documentation |
| Pharmacaribe, LLC | Devices | 08/20/2025 | DMR – not or inadequately maintained |
| Pharmacaribe, LLC | Devices | 08/20/2025 | Investigation of device failures |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
