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        Inspections, Compliance, Enforcement, and Criminal Investigations

Inspections, Compliance, Enforcement, and Criminal InvestigationsOperation Lascar
          Inspection Classification Database


                Compliance Manuals
          Inspection Basics
          Compliance Actions and Activities
          Criminal Investigations
          Inspection References Home Inspections, Compliance, Enforcement, and Criminal Investigations
  
  			 
		FDA's Office of Regulatory Affairs (ORA) - working to keep your community safe.Topic Paragraphs
          Regulatory Science and Innovation
  
  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 Latest
          What We're Doing to Keep You Safeglobal inspections

                    Conducting Inspections Around the Globe
            Inspecting FDA-regulated facilities worldwide to ensure industry compliance with federal laws and rigorous quality standards
    
          Scientists in a lab working at a computer

                    Leveraging Science
            Engaging the latest science—from artificial intelligence to food technologies —all in the quest to keep you safe
    
          import port

                    Screening Imported Goods
            Ensuring the safety of imported FDA-regulated products before they reach U.S. consumers
    
          Fake Drugs

                    Protecting Against Health Fraud Scams
            Keeping you informed about the latest health product scams - and pursuing the bad actors who perpetuate them
    
          Global partnerships

                    Building Partnerships
            Building a world of partners to bolster our public health mission
    
          food processing conveyor belt

                    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.
      
      Jan 30

  Byrne Dairy Recalls Mighty Fine Chocolate Ice Cream in Half Gallons Dated 10/4/2024 Due to Undeclared Peanuts 

  Food & BeveragesJan 29

  Truong Giang Distributor Corp Issues Allergy Alert on Undeclared Sulfites in Dried Mango 

  Food & BeveragesJan 28

  Neptune Resources, LLC Issues Voluntary Nationwide Recall of Neptune’s Fix 

  Drugs
      
				More Recalls Market Withdrawals & Safety Alerts
          Enforcing U.S. public health laws and helping put bad actors behind bars
      Recent Criminal Investigation Press Releases
      
      Jan 24

  Former Employee of Medical Device Manufacturer Sentenced for Forging Two FDA Letters that Led to Illegal Sale of Medical DevicesJan 12

  Texas Company Pleads Guilty to Distributing Misbranded Dietary Supplements and Agrees to $4.5 Million ForfeitureJan 12

  Pharmacist Sentenced for Illegally Dispensing Promethazine Cough Syrup and Earning Millions in Profits
  
            View All OCI Press Releases
          What We Inspectgrocery cart

                    Food
            Safeguarding more than $1.5 trillion worth of food and providing educational resources related to food safety, cosmetics, and dietary supplements
    
          spilled pills

                    Drugs
            Ensuring safe and effective drugs are available to improve the health of all Americans
    
          A drawing of blood cells

                    Vaccines, Blood & Biologics
            Ensuring blood, blood products, vaccines, and biological products are safe, effective, and available to those who need them
    
          medical device in hospital

                    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
    
          Dog and kitten

                    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 and cigarettes

                    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
    
          Cosméticos

                    Cosmetics
            Regulating cosmetics for safe use and proper labeling
          You Can HelpReport a Problem to the FDA
        Consumers play an important role in public health by reporting to FDA any adverse reactions or other problems with products the agency regulatesReport Suspected Criminal Activity
        If you wish to report suspected criminal activity relating to FDA regulated products, please describe the suspected criminal activity in detail to the Office of Criminal InvestigationMedWatch: The FDA Safety Information and Adverse Event Reporting Program
        MedWatch is the FDA’s medical product safety reporting program for health professionals, patients and consumers
          Getting to Know ORAYou want to make a difference, FDA wants to hire you.

                    Jobs at the Office of Regulatory Affairs (ORA)
    
          i am ora logo

                    I Am ORA
          About the Office of Regulatory AffairsThe 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.

  Read more about the Office of Regulatory Affairs
        
        Meet the Associate Commissioner for Regulatory Affairs
          Contact ORAFollow us on TwitterFDA Recalls on TwitterContact ORA
          NAVIGATE THE INSPECTION , COMPLIANCE, ENFORCEMENT AND CRIMINAL INVESTIGATIONS SECTIONCompliance Manuals
        Official documents, lists, policies, programs, and statements relating to Compliance References used by FDA personnelCompliance Actions and Activities
        Compliance activities including enforcement actions and reference materials such as policies and program descriptionsInspection References
        Information provided to assist FDA investigators and inspectors in their daily activitiesCriminal Investigations
        Information, news and contact information related to FDA's Criminal Investigation Activities
          Compliance Actions & ActivitiesWarning LettersFDA Debarment ListsClinical Investigator - Disqualification ProceedingsAdvisory LettersIssuance of Untitled LettersFDA Bioresearch Monitoring InformationEnforcement ActivityApplication Integrity Policy
          Manuals & GuidanceCompliance ProgramsCompliance Policy Guides (CPGs)Regulatory Procedures Manual (RPM)Investigations Operations Manual (IOM)
          More Inspection ReferencesInspection Classification DatabaseInspection CitationInspection ObservationsInspection GuidesForeign InspectionsNonclinical Laboratories Inspected under Good Laboratory PracticesORA Outbreak Response Field GuidesField Management Directives
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