Rochester Reporter

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