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Wednesday, December 4, 2024

Alabama: Biologics companies were the second most FDA inspected companies in Alabama in Q1 2023

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Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

In the first quarter of 2023, three Biologics companies received three FDA inspections in Alabama, according to the U.S. Food and Drug Administration (FDA).

This was the second highest number of inspections per type of company made by the FDA in Alabama, equalling 12% of all inspections in the first quarter of 2023.

Of all the Alabama companies involved in the Biologics sector, Alabama Fertility Specialists, PC received the most citations from the FDA 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.

FDA Inspections in Alabama During Q1 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring3----
Blood and Blood Products11--
Compliance: Devices1----
Foodborne Biological Hazards11--1
Human Cellular, Tissue, and Gene Therapies11--
Monitoring of Marketed Animal Drugs, Feed, and Devices1----
Technical Assistance: Food and Cosmetics31--
Tobacco Post-Market Activities--1--
Vaccines and Allergenic Products21--

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