The 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 13 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.
Food and Feed Laboratory Operations
The Office of Food and Feed Laboratory Operations (OFFLO) oversees eight laboratories and associated programmatic staff. OFFLO 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.
- Arkansas Lab (ARKL)
- Denver Laboratory (DENL)
- Kansas City Laboratory (KCL)
- Northeast Food and Feed Laboratory (NFFL)
- Pacific Northwest Laboratory (PNL)
- Pacific Southwest Food and Feed Laboratory (PSFFL)
- San Francisco Laboratory (SANFL)
- Southeast Food and Feed Laboratory (SFFL)
Medical Products, Tobacco, and Specialty Laboratories
The Office of Medical Products, Tobacco, and Specialty Laboratory Operations (OMPTSLO) oversees eight laboratories and associated programmatic staff. OMPTSLO 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.
- Detroit Laboratory (DETL)
- Forensic Chemistry Center (FCC)
- Northeast Medical Products Laboratory (NMPL)
- Pacific Southwest Medical Products Laboratory (PSMPL)
- Philadelphia Laboratory (PHIL)
- San Juan Laboratory (SJNL)
- Southeast Tobacco Laboratory (STL)
- Winchester Engineering Analytical Center (WEAC)