How to Report Product Problems and Complaints to the FDA | FDA – FDA.gov

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If you have an unexpected reaction or other problem with any FDA regulated product, the agency wants to hear from you.
The U.S Food and Drug Administration protects the public health by helping to ensure the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, and products that emit radiation—and by helping to ensure the safety and security of our nation’s food supply and cosmetic products. The FDA also regulates tobacco products.
If you have a problem or concern about any of the products that the agency regulates, the FDA wants to hear from you.
You can report the problem online, via phone, or via mail.
FDA-regulated products account for about 20 cents of every dollar of annual spending by U.S. consumers, and you can report problems about any products that the FDA regulates. These products include:
An extended list of products that the FDA regulates is online.
Information about problems or unexpected reactions can help the FDA protect the public health.
For instance, if you report a problem to the FDA, you could help identify an unknown risk. And your report could help the FDA know when to carry out preventive and protective actions, which can include requiring labels to provide new warning information and issuing safety messages to the public. Products also can be potentially removed from the market.
If you have a medical emergency related to an FDA-regulated product, call 9-1-1 and seek medical assistance immediately. After you’ve received the medical attention that you need, you can report the issue to the FDA.
Note: Even if you have a problem and do not seek medical attention, you still can report the issue to the FDA. Similarly, you can report problems with animal drugs or devices or animal food, whether you sought veterinary assistance or not.
Examples of problems you can report include:
“If it’s serious to you, we want to know,” says Anna Fine, Pharm.D., M.S., director of the FDA’s Health Professional Liaison Program. She adds that you should report an issue even if you’re not sure a particular product was the cause.
You can report a problem to the FDA online, via phone, or via mail.
For emergencies:
For non-emergencies:
“We recognize it can be challenging to figure out where to report concerns or problems to the FDA,” Fine notes. “Ideally you will submit a report through the designated reporting system, but if you submit a report through any of our systems, it will ultimately get to the right place in the agency.”
Submit as much detailed information as possible.
For products for humans, try to provide the following information.
Similarly, for products for animals, detailed information about the affected animal(s), the product, and the health problem(s) noted is helpful.
Include any product codes, numbers, and dates on the packaging and labeling. If needed, this can help the FDA trace the product back to the place of manufacture.
In addition to reporting to the FDA, consider reporting the problem to the manufacturer and the store where you bought the product.
And if you have any reporting questions, you can call your local FDA Consumer Complaint Coordinator.
10/26/2016
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