Conducting Inspections Around the Globe
Inspecting FDA-regulated facilities worldwide to ensure industry compliance with federal laws and rigorous quality standards
Inspections, Compliance, Enforcement, and Criminal Investigations
FDA's Office of Regulatory Affairs (ORA) - working to keep your community safe.
Topic Paragraphs
ORA News, Stories, and Features
Our vision. Our people. Our everyday efforts to keep you safe. Connect to the latest news, perspectives, and stories from staff.
Read the LatestWhat We're Doing to Keep You Safe
Leveraging Science
Engaging the latest science—from artificial intelligence to food technologies —all in the quest to keep you safe
Screening Imported Goods
Ensuring the safety of imported FDA-regulated products before they reach U.S. consumers
Protecting Against Health Fraud Scams
Keeping you informed about the latest health product scams - and pursuing the bad actors who perpetuate them
Building Partnerships
Building a world of partners to bolster our public health mission
Providing Guidance to Industry
Working with industry to support an innovative marketplace that's safe for all consumers and patients
Recalls, Market Withdrawals, & Safety Alerts
Alerting you to the latest recalls of potentially unsafe FDA-regulated products gathered from press releases and other public notices. Not all recalls have press releases or are posted on this website.
Oct 07
Philips Respironics Issues Additional Usage Instructions for Trilogy Evo Ventilators Related to Use of In-Line Nebulizers
Medical Devices
Oct 04
Jacks and the Green Sprouts Recalls Alfalfa and Alfalfa Onion Sprouts Because of Possible Health Risk
Food & Beverages
Oct 04
Lunds & Byerlys Voluntarily Recalls L&B Lone Star Dip Due to Potential Mold
Food & Beverages
Enforcing U.S. public health laws and helping put bad actors behind bars
Recent Criminal Investigation Press Releases
Oct 03
Ten Pharmaceutical Distributor Executives, Sales Representatives, and Brokers Charged in Connection with Unlawful Sales of Nearly 70M Opioid Pills
Oct 02
Florida Company Charged with Conspiring to Sell Misbranded N95 Masks to Hospital in Early Months of COVID-19 Pandemic
Sep 25
27 Individuals Indicted for Buying and Selling Wholesale Quantities of Misbranded and Diverted Prescription Drugs Resold to the Public Through Retail Pharmacies in Puerto Rico
What We Inspect
Food
Safeguarding more than $1.5 trillion worth of food and providing educational resources related to food safety, cosmetics, and dietary supplements
Drugs
Ensuring safe and effective drugs are available to improve the health of all Americans
Vaccines, Blood & Biologics
Ensuring blood, blood products, vaccines, and biological products are safe, effective, and available to those who need them
Medical Devices & Radiation-Emitting Products
Assuring U.S. patients have access to safe, effective, and high-quality medical devices and radiation-emitting products, like mammograms and other x-ray imaging
Animal & Veterinary
Protecting pet health by regulating the drugs, devices, and feed given to or used on companion and food-producing animals in the U.S.
Tobacco Products
Protecting Americans from tobacco-related disease and death by regulating the manufacture, distribution, and marketing of tobacco products to ensure a healthier life for every family
Cosmetics
Regulating cosmetics for safe use and proper labeling
Getting to Know ORA
About the Office of Regulatory Affairs
The U.S. Food and Drug Administration’s Office of Regulatory Affairs (ORA) is the lead office for all agency field activities. ORA inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States. In pursuit of its mission, ORA also works with its state, local, tribal, territorial and foreign counterparts.