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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Center for Drug Evaluation and Research - Post-Approval Safety Monitoring - Compliance Dashboard

Policy and Science

FDA’s Center for Drug Evaluation and Research (CDER) regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. CDER also regulates other non-medicines that are considered to be drugs like fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens. CDER protects and advances public health by ensuring safe and effective drugs are available to improve the health of people in the United States.

FDA has established a wide array of guidance and regulations to help assure patients have access to high-quality over-the-counter and prescription medications that are safe and effective. CDER diligently works to ensure compliance through facility inspections, product testing, and other pre- and postmarket actions, including enforcement actions, in the United States and globally. This work includes oversight of clinical trials, commercial manufacturing of raw and finished products, compounded drugs, supply chain integrity, drug recalls, product labels, drug registration and listing, and post-market safety requirements.


Download Compliance Dataset PDF / Print Version


  1. The inspections and Form FDA 483 information represents data that is tracked by CDER.
  2. For the Form FDA 483 measure only, as of FY 2021 Q1, CDER is no longer tracking the number of 483's posted by ORA. Refer to the ORA Electronic Reading Room for posted documents.
  3. For the Form FDA 483 measure only, of the total number of inspections, data represents the number of inspection types for which a Form FDA 483 was issued.
  4. The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. The data presented in the visualizations above can be accessed by clicking on the link labeled "Download Compliance Dataset" located right below the visualizations.


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