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Rochester Reporter

Thursday, October 31, 2024

How many companies in cities across Monroe County received FDA citations in Q3?

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Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

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

This is a 66.7% decrease from the number of companies cited in the previous quarter.

The only citation issued in the county was delivered as 'The responsibilities and procedures applicable to the quality control unit are not'.

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.

Companies located within Monroe County Cities and the citations they received in Q3
Company NameArea of BusinessInspection DateIssue Cited
Airgas USA, LLCDrugs07/31/2024Procedures not in writing, fully followed

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