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Sunday, December 22, 2024

How many companies in cities in Bucks County received FDA inspections in Q1 2023?

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Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

There were six companies in cities associated with Bucks County, Pennsylvania, that received six FDA inspections in the first quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 25% decrease from the number of companies inspected in the previous quarter, when eight companies received eight inspections.

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

There were four companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions. Two should take voluntary action to correct their management operations.

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 Cities Within Bucks County and Their Inspection Results
Company NameArea of BusinessInspection DateResult
ARCH-QuakertownDevices01/13/2023No Action Indicated (NAI)
Axial MedicalDevices03/10/2023No Action Indicated (NAI)
PEL Healthcare, LLCDrugs01/13/2023Voluntary Action Indicated (VAI)
Reproductive Medicine Associates Of Philadelphia, P.C.Biologics01/24/2023No Action Indicated (NAI)
SigmaPharm Laboratories, LLCDrugs02/13/2023No Action Indicated (NAI)
Thrombolex, Inc.Devices03/30/2023Voluntary Action Indicated (VAI)

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