Monroe NY News

There was one company in a city associated with Monroe County that received FDA citations as a result of one inspection conducted in the county over the first quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is unchanged from the number of companies cited in the previous quarter.

The citations in the county were 'Schedules for the adjustment, cleaning, and other maintenance of equipment have not been adequately established' and 'Software used as part of production has not been adequately validated for its intended use according to an established protocol'.

The company cited should take a voluntary action to correct its 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.

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, according to its website.

Company Name	Area of Business	Inspection Date	Issue Cited
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