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 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 40% decrease from the number of companies cited in the previous year.
The citations in the county include:
- Procedures to ensure equipment is routinely calibrated have not been adequately established.
- Procedures have not been adequately established to control product that does not conform to specified requirements.
- Procedures for corrective and preventive action 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.
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 |
|---|---|---|---|
| Halperns’ Steak and Seafood Company, LLC | Food and Cosmetics | 02/02/2024 | No HACCP plan |
| Summit Orthopedic Technologies, Inc. | Devices | 02/15/2024 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| Summit Orthopedic Technologies, Inc. | Devices | 02/15/2024 | Nonconforming product, Lack of or inadequate procedures |
| Summit Orthopedic Technologies, Inc. | Devices | 02/15/2024 | Lack of or inadequate procedures |
| Summit Orthopedic Technologies, Inc. | Devices | 02/15/2024 | Review and evaluation for investigation |
| United Product Development, Corp. | Food and Cosmetics | 07/05/2024 | Sanitary facilities and controls |
| United Product Development, Corp. | Food and Cosmetics | 07/05/2024 | Process preventive controls – Identify (Written) |
| United Product Development, Corp. | Food and Cosmetics | 07/05/2024 | Process preventive controls – Implementation records |



