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Thursday, November 21, 2024

FDA conducted second lowest number of inspections on Drugs companies in New York during Q4 2023

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James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

In the fourth quarter of 2023, nine Drugs companies received nine FDA inspections in New York, according to the U.S. Food and Drug Administration (FDA).

This was the second lowest number of inspections per type of company made by the FDA in New York, equalling 7.9% of all inspections in the fourth quarter of 2023.

Of all the New York companies involved in the Drugs sector, Phoenix Wipes, Inc. received the most citations from the FDA in the fourth 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 New York During Q4 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring4----
Blood and Blood Products44--
Compliance: Devices68--
Drug Quality Assurance25--
Food Composition, Standards, Labeling and Econ42--
Foodborne Biological Hazards4422--
Human Cellular, Tissue, and Gene Therapies42--
Monitoring of Marketed Animal Drugs, Feed, and Devices31--
Postmarket Assurance: Devices131--
Technical Assistance: Food and Cosmetics41--

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