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                Report a Problem to the FDA

Report a Problem to the FDA

                        When and Where to Report Emergencies
          How to Report a Non-Emergency
          Reporting Unlawful Sales of Medical Products on the Internet


                        Consumer Complaint Coordinators
          Questions and Answers: Problem Reporting Home
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          Report a Problem to the FDA
          How to Report a Non-EmergencyReport a Problem to the FDA How to Report a Non-Emergency
  
  	
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    PrintHow do I report non-emergencies about:FoodDietary SupplementsMedicines, Medical Devices, Blood Products, Biologics, Special NutritionalsVaccinesBlood Transfusions and DonationsAnimal FeedVeterinary ProductsCosmeticsTobaccoRadiological Health ProductsHow do I report non-emergencies about food?If you are a consumer, health professional, or member of the food industry who wants to voluntarily report a complaint or adverse event (illness or serious allergic reaction) related to any food product except meat and poultry, you have three choices:Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.Complete an electronic Voluntary MedWatch form online.Complete a paper Voluntary MedWatch form that can be mailed to FDA.If the problem involves meat or poultry, which are regulated by the U.S. Department of Agriculture, please call USDA Meat and Poultry Hotline at 1-888-MPHotline (1-888-674-6854).[Top]How do I report non-emergencies about dietary supplements?If you are a consumer or health professional who wants to voluntarily report defects in the quality or safety of a dietary supplement or an adverse event (illness or serious allergic reaction) related to a dietary supplement, please visit the Safety Reporting Portal.[Top]How do I report non-emergencies about medical products: medicines, medical devices, blood products, biologics, special nutritionals?MedWatch -- The FDA Safety Information and Adverse Event Reporting Program allows healthcare professionals and consumers to voluntarily report serious problems that you suspect are associated with the drugs and medical devices they prescribe, dispense, or use. These problems include serious adverse reactions and events, product quality problems, and product use errors. Reporting can be done online, by phone, or by submitting the MedWatch 3500 form by mail or fax. Visit the MedWatch How To Report page for more details.[Top]How do I report non-emergencies about vaccines?Adverse reactions and other problems related to vaccines should be reported to the Vaccine Adverse Event Reporting System, which is maintained by FDA and the Centers for Disease Control and Prevention. For a copy of the vaccine reporting form, call 1-800-822-7967 or get a copy of the form from the FDA Website.[Top]How do I report non-emergencies about blood transfusions and donations?You can make initial notifications of transfusion-related fatalities and donation-related deaths to FDA's Center for Biologics Evaluation and Research.[Top]How do I report non-emergencies about animal feed/food or pet food/treats?If you are a manufacturer, report problems with reportable animal feed through the Safety Reporting Portal.If you are a consumer, you may report problems with pet food through the Safety Reporting Portal or contact the district office consumer complaint coordinator for your geographic area.[Top]How do I report non-emergencies about veterinary products?If you are a manufacturer, report adverse drug events through the Safety Reporting Portal or use FDA’s Gateway to Gateway reporting. For additional information, see Veterinary Adverse Event Reporting for Manufacturers.If you are a consumer, report any problems with veterinary drugs and devices for animals to FDA's Center for Veterinary Medicine at 1-888-FDA-VETS (1-888-332-8387). You can also find the reporting form on the center's Website. For more information, see Veterinary Adverse Event Voluntary Reporting.[Top]How do I report non-emergencies about cosmetics?If you are a consumer, health professional, or member of the cosmetics industry who wants to voluntarily report a complaint or adverse event (illness or serious allergic reaction) related to a cosmetic, you have three choices:Call a FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.Complete an electronic Voluntary MedWatch form online.Complete a paper Voluntary MedWatch form that can be mailed to FDA.[Top]How do I report non-emergencies about tobacco products?If you are a consumer or health care professional, you may report an unexpected health or safety issue with a specific tobacco product, through the Safety Reporting Portal.[Top]How do I report non-emergencies about electronic products that give off radiation?If you are a consumer or health care professional who wants to voluntarily report a suspected radiation-related problems or injuries, you can directly report to the FDA by completing and mailing the Accidental Radiation Occurrence Report form.[Top]ResourcesForYouMedWatch: The FDA Safety Information and Adverse Event Reporting ProgramGet Email UpdatesWhat Happens When a Problem is Reported?FDA Patient Safety News Video Broadcasts

                                                                                  Content current as of:
      03/29/2018
              
              
Topic(s)
			  Consumer Health
				    				       				    					
				  
				  
				  
				  
				   
				  
				  				  Safety - Issues, Errors, and ProblemsReport a Problem to the FDA

          
                        When and Where to Report Emergencies
          How to Report a Non-Emergency
          Reporting Unlawful Sales of Medical Products on the Internet


                        Consumer Complaint Coordinators
          Questions and Answers: Problem Reporting
 
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