Management Systems

U.S. FDA Complains

US FDA complaint is a way to report a problem with a product that is regulated by the U.S. Food and Drug Administration (FDA). The FDA is responsible for protecting public health by ensuring the safety and effectiveness of drugs, medical devices, food, cosmetics, and other products.

The US Food and Drug Administration (FDA) considers complaints a valuable source of information for risk management of medical devices and other FDA-regulated products. Here’s how complaints and risk management intertwine:

  • Identification of Risks : Complaints can highlight potential safety issues with a product that may not have been identified during pre-market testing. By analyzing complaints, manufacturers can gain insights into real-world use and uncover unforeseen risks.
  • Risk Assessment : The FDA expects manufacturers to have a risk management plan in place. Information from complaints feeds into this plan by helping assess the likelihood and severity of potential harm associated with the identified risks.
  • Corrective and Preventative Actions (CAPA) : When a complaint reveals a serious risk, manufacturers are required to take corrective and preventative actions (CAPA) to address the issue. This might involve recalling a product, issuing a safety alert, or modifying the design or manufacturing process.