There were seven companies in a city associated with Monroe County that received FDA citations as a result of seven inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 133.3% increase over the number of companies cited in the previous year.
The citations in the county include:
- Plumbing is not maintained so as to prevent contamination of the water supply.
- A water system not protected against backflow.
- Procedures for management review have not been established.
Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked 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 quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Advantage Metalwork and Finishing, LLC | Devices | 02/29/2024 | Management review – Lack of or inadequate procedures |
| Advantage Metalwork and Finishing, LLC | Devices | 02/29/2024 | Quality audits – Lack of or inadequate procedures |
| Advantage Metalwork and Finishing, LLC | Devices | 02/29/2024 | Purchasing controls, Lack of or inadequate procedures |
| Advantage Metalwork and Finishing, LLC | Devices | 02/29/2024 | Software validation for automated processes |
| Advantage Metalwork and Finishing, LLC | Devices | 02/29/2024 | Calibration procedures – content |
| Advantage Metalwork and Finishing, LLC | Devices | 02/29/2024 | Lack of or inadequate process validation |
| Advantage Metalwork and Finishing, LLC | Devices | 02/29/2024 | Nonconforming product, Lack of or inadequate procedures |
| Advantage Metalwork and Finishing, LLC | Devices | 02/29/2024 | Lack of or inadequate procedures |
| Advantage Metalwork and Finishing, LLC | Devices | 02/29/2024 | DMR – not or inadequately maintained |
| Airgas USA, LLC | Drugs | 07/31/2024 | Procedures not in writing, fully followed |
| American Airlines | Food and Cosmetics | 04/25/2024 | Backflow protection |
| Nalge Nunc International Corporation | Devices | 01/05/2024 | Maintenance schedule, Lack of or inadequate schedule |
| Nalge Nunc International Corporation | Devices | 01/05/2024 | Software validation for automated processes |
| Nathan’s Soup and Salad Henrietta, Inc. | Food and Cosmetics | 06/27/2024 | Sanitation monitoring |
| The ICEE Company | Food and Cosmetics | 06/25/2024 | Pest control |
| United Airlines | Food and Cosmetics | 04/25/2024 | Plumbing design, installation, maintenance |
