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Tuesday, April 22, 2025

California: Biologics companies were the second most FDA inspected companies in California in Q1

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Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

In the first quarter of 2025, 22 Biologics companies received 23 FDA inspections in California, 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 California, equalling 13.2% of all inspections in the first quarter of 2025.

Of all the California companies involved in the Biologics sector, Tox Laboratory, M.D. and Pacific Reproductive Center received the most citations from the FDA in the first quarter of 2025.

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.

According to its website, 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.

Top 10 FDA Inspections by Number of Actions Indicated in California During Q1
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1
Blood and Blood Products9
Compliance: Devices42
Drug Quality Assurance331
Food Composition, Standards, Labeling and Econ428
Foodborne Biological Hazards8432
Human Cellular, Tissue, and Gene Therapies86
Monitoring of Marketed Animal Drugs, Feed, and Devices13
Postmarket Assurance: Devices51
Technical Assistance: Food and Cosmetics102

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