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Sunday, November 24, 2024

Massachusetts: Biologics companies were the least FDA inspected companies in Massachusetts in Q1 2023

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Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

In the first quarter of 2023, one Biologics company received an FDA inspection in Massachusetts, according to the U.S. Food and Drug Administration (FDA).

This was the lowest number of inspections per type of company made by the FDA in Massachusetts, equalling 2.4% of all inspections in the first quarter of 2023.

The FDA routinely inspects facilities across the nation to determine if the workplaces and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly for businesses to consistently make smarter business decisions for the future.

The FDA is a government agency primarily responsible for monitoring the manufacturing and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Top 10 FDA Inspections by Number of Actions Indicated in Massachusetts During Q1 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring31--
Compliance: Devices15--
Drug Quality Assurance121
Food Composition, Standards, Labeling and Econ2----
Foodborne Biological Hazards178--
Monitoring of Marketed Animal Drugs, Feed, and Devices--1--
Postmarket Assurance: Devices5----
Radiation Control and Health Safety Act--1--
Technical Assistance: Food and Cosmetics2----
Unapproved and Misbranded Drugs----1

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