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Friday, May 3, 2024

How many companies in cities in Monroe County received FDA inspections in 2023?

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Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

There were four companies in a city associated with Monroe County, Indiana, that received four FDA inspections in 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 100% increase over the number of companies inspected in the previous year, when two companies were inspected through two inspections.

Most of the companies inspected were involved in the Drugs sector. The second most common type of company inspected in the time period worked in the Biologics sector.

There were two companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions. One should take voluntary action to correct the organization's management operations. Additionally, one company had to take regulatory and/or administrative actions.

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 in a City Within Monroe County and Their Inspection Results
Company NameArea of BusinessInspection DateResult
Baxter Pharmaceutical Solutions, LLCDrugs02/17/2023No Action Indicated (NAI)
BioLife Plasma Services, L. PBiologics03/16/2023No Action Indicated (NAI)
Catalent Indiana, LLCBiologics11/15/2023Voluntary Action Indicated (VAI)
Catalent Indiana, LLCDrugs11/15/2023Voluntary Action Indicated (VAI)
KP Pharmaceutical TechnologyDrugs02/03/2023Official Action Indicated (OAI)

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