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Field Science and Laboratories

Detroit District Lab EquipmentThe success of FDA activities to protect the public health often depends on the ability of the Agency's laboratories to quickly and accurately analyze samples. To prevent distribution of a product that has been found to be in violation of the Food, Drug and Cosmetic Act, FDA uses its nationwide network of laboratories to analyze samples and report results for regulatory action.

The Office of Regulatory Affairs (ORA), Office of Regulatory Science (ORS), operates 15 laboratories, located strategically across the United States, to support FDA's mission to protect the public health and to create new knowledge in the field of regulatory science. The labs specialize as Human and Animal Food (HAF) Labs or Medical Products, Tobacco, and Specialty (MPTS) Labs.  Below are profiles for each of ORA's field laboratories.

ORA's Laboratory Manual, available in the left navigation area, is the reference manual for ORA laboratory personnel. It provides ORA personnel with information on internal procedures to be used as an agency policy for testing consumer products, training of laboratory staff, report writing, safety, research, review of private laboratory reports and court testimony.  This document is maintained as part of ORA’s Quality Management System document control process and is available on the FDA public website. 

Read more about the Office of Regulatory Science.

 

Food and Feed Laboratory Operations

The Office of Human and Animal Food Laboratory Operations (OHAFLO) oversees eight laboratories and associated programmatic staff. OHAFLO provides oversight on scientific issues and laboratory analysis related to the chemical and microbiological analysis of human and animal food. It works with appropriate FDA centers and other stakeholders to establish and execute strategic and tactical plans for the effective use of science resources in ORA.

Medical Products, Tobacco, and Specialty Laboratories

The Office of Medical Products and Specialty Laboratory Operations (OMPSLO) oversees eight laboratories and associated programmatic staff. OMPSLO provides oversight on scientific issues and laboratory analysis related to pharmaceuticals, tobacco, medical devices, radiochemistry, and forensic chemistry. It works with appropriate FDA centers and other stakeholders to establish and execute strategic and tactical plans for the effective use of science resources in ORA.

Pharmaceutical Microbiology Resources

Other Resources



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