The Food and Drug Administration (FDA) conducts inspections and assessments of regulated facilities of pharmaceutical industry to determine the organization’s compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic (FD&C) Act and related Acts.
FDA discloses some of inspection information to help improve the public’s understanding of how the FDA works to protect the public health. Disclosure of an inspection information encourages to comply with FD&C act.
Some inspection data may be not be public until a final enforcement action is taken. Following database does not represent a comprehensive listing of all conducted inspections and should not be used as a source to compile official data.
FDA's System-generated 483s
FDA’s Office of Regulatory Affairs (ORA) is the lead office for all field activities, including inspections and enforcement. During an inspection, ORA investigators may observe conditions they deem to be objectionable. These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.
Read also: FDA Inspection Checklist
