FDA Facility Inspectors and Auditors – An Overview

By Harry   07/15/2021

  Category: Other Blogs


The Food and Drug Administration is an entity in the United States that is managed and controlled by the United States government. It aims is to protect public health by verifying that food, drugs, nutritional supplements are safe to use and accurately labelled. It is a government agency which is basically under the Department of Health and Human Services. The headquarters of the FDA is located in White Oak, Maryland. The FDA is controlled by the commissioner of food and drugs, elected by the president with the group’s approval and consent. Facility auditor is one who does thorough examination of facilities or lab’s assets.

Additionally, the agency maintains 223 field offices and 13 laboratories spread across the 50 states, including the US Virgin Islands and Puerto Rico. The FDA began sending staff to countries like China, India, Costa Rica, etc., in 2008. The FDA monitors and controls food safety, tobacco products, nutritional supplements, vaccines, pharmaceutical drugs, organ transplants, electromagnadiation, cosmetics, drugs, animal foods, and dietary supplements.

The FDA in brief

On 31st March 2019, the FDA began the process of redesigning its organization. The FDA’s reorganization demonstrates the agency’s commitment to modernizing its system to achieve better its purpose of protecting and promoting public health and meeting the challenges of rapid innovation in the industries it regulates. The FDA is in charge of ensuring the safety, efficiency, biological products, medical devices, our nation’s food supply, cosmetics, and radioactive materials to protect public health.

It intends to promote FDA communication by making essential governmental procedure services easily accessible to businesses in a user-friendly manner.

What type of things does the Facility Inspectors?

The FDA facility inspections manufacturer to ensure that they are following statutory regulations. It is also under for various reasons, such as projects or in response to a reported problem. They are also inspected as: –

  • Vaccines and drugs.
  • Food processing facilities – Dairy farms, and so on.
  • It inspects facilities that will conduct human research.
  • Processing sites for FDA-regulated products sold in United States laboratories for conducting education related to this and then will be used for approval.
  • The Facility inspections conduct a variety of inspections to protect customers from dangerous items
  • It is a routine inspection of regulated facilities.
  • “For-cause” is an investigation to look into specific issues that have come to the FDA’s attention.

What do the FDA auditors look for?

Facility auditors look for an inspector who want to see that you have implemented any necessary risk management processes and continuously monitor the risks identified in operation – calibration and maintenance reports for equipment and instruments.


Science and technology advancements are accelerating, presenting extraordinary challenges and opportunities in the United States and worldwide. It is responsible for preserving and promoting the nation’s health and also regulating innovative enterprises. The strategic plan for regulatory science highlights critical issues and activities where new and increasing government scientific research collaboration is critical to the project’s continuing success. For many years, the FDA’s work was funded by US taxpayers until new infectious diseases destroyed that structure.

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