There were nine companies in cities associated with Lee County that received FDA citations as a result of 10 inspections conducted in the county in 2025, according to the U.S. Food and Drug Administration (FDA).
This is an 80% increase over the number of companies cited in the previous year.
Of the 27 citations issued, the most common citations were ‘You did not implement adequate monitoring and verification for foods that require temperature control for safety’ and ‘You did not establish and maintain records documenting temperature controls for foods that require temperature control for safety’.
Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company operated in the Devices 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.
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 |
|---|---|---|---|
| A Tu Gusto, LLC | Food and Cosmetics | 05/23/2025 | Manufacturing, processing, packing, holding – Controls |
| A Tu Gusto, LLC | Food and Cosmetics | 05/23/2025 | HACCP plan implementation |
| A Tu Gusto, LLC | Food and Cosmetics | 05/23/2025 | Food safety hazards |
| A Tu Gusto, LLC | Food and Cosmetics | 05/23/2025 | Corrective action plan |
| A Tu Gusto, LLC | Food and Cosmetics | 05/23/2025 | Signed and dated |
| A Tu Gusto, LLC | Food and Cosmetics | 05/23/2025 | Sanitation monitoring |
| American Contract Systems, Inc. | Devices | 03/21/2025 | Procedures for product review,disposition lack of/inadequate |
| Erickson & Jensen Seafood Packers | Food and Cosmetics | 03/13/2025 | Sanitation Records |
| Leesar, Inc. | Devices | 07/18/2025 | Management review – Lack of or inadequate procedures |
| Leesar, Inc. | Devices | 07/18/2025 | Quality audits – Lack of or inadequate procedures |
| Leesar, Inc. | Devices | 07/18/2025 | Management review – defined interval, sufficient frequency |
| Leesar, Inc. | Devices | 07/18/2025 | Quality System Procedures |
| Leesar, Inc. | Devices | 07/18/2025 | Documentation of validated process performance |
| Leesar, Inc. | Devices | 07/18/2025 | Lack of or inadequate procedures |
| Leesar, Inc. | Devices | 07/18/2025 | Investigation of device failures |
| Leesar, Inc. | Drugs | 05/09/2025 | Procedures not in writing, fully followed |
| Leesar, Inc. | Drugs | 05/09/2025 | Absence of Written Procedures |
| Leesar, Inc. | Drugs | 05/09/2025 | Records reviewed annually |
| Leesar, Inc. | Drugs | 05/09/2025 | Investigations of discrepancies, failures |
| McArthur Next, LLC | Food and Cosmetics | 10/09/2025 | Modified requirement: Temperature control – Implement |
| McArthur Next, LLC | Food and Cosmetics | 10/09/2025 | Modified requirement: Temperature control – Records |
| Merits Health Products, Inc. | Devices | 02/27/2025 | Lack of or inadequate procedures |
| Merits Health Products, Inc. | Devices | 02/27/2025 | Lack of or inadequate complaint procedures |
| Merits Health Products, Inc. | Devices | 02/27/2025 | Evaluation, timeliness, identification |
| Peterson Brands, LLC | Food and Cosmetics | 05/20/2025 | Sanitation monitoring |
| Total Food Logistics, LLC | Food and Cosmetics | 10/02/2025 | Modified requirement: Temperature control – Implement |
| Total Food Logistics, LLC | Food and Cosmetics | 10/02/2025 | Modified requirement: Temperature control – Records |
