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  1. Guidance, Compliance, & Regulatory Information

Pharmaceutical Inspections and Compliance

Current Good Manufacturing Practice (CGMP) Inspections and Compliance

Inspections Help Ensure Drug Safety and Quality

FDA works to ensure the medications that are available to hospitals, health systems and patients are safe, effective and of high quality. For application products, typically prescription drugs, FDA’s approval process is the first step. FDA’s drug application approval includes assessing the manufacturing process and the facility, including information the agency gained through inspections or alternative tools, to ensure the proposed manufacturing process can be performed in compliance with applicable standards and produce high-quality drugs.

In addition, FDA oversees the safety and quality of medications that are not marketed under an approved application, including over-the-counter monograph and compounded drugs.

More on how FDA Evaluates and Ensures Compliance:

All Drugs Manufactured for the U.S. Market Must Meet FDA's Rigorous Standards

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FDA's Data Dashboard provides detailed information about FDA’s inspection, compliance, recall and import actions from 2009 to present. 

FDA monitors drugs on the market to help assure they meet FDA requirements for safety and quality regardless of whether they are an application drug. All drugs manufactured for the U.S. market, whether manufactured domestically or abroad, must meet the same rigorous standards.

It is the industry’s responsibility to comply with the law regarding drug safety and quality. Key requirements for drug manufacturing quality include relevant provisions of the FD&C Act and FDA’s current good manufacturing practice (CGMP) regulations.

FDA's CGMP Requirements Keep Consumers and Patients Safe

CGMP requirements were purposefully engineered with multilayered processes, controls and quality oversight that are designed to produce high quality drugs and to detect and quickly mitigate potential issues before harm to patients or consumers occurs. When properly implemented, the requirements help ensure drugs are safe, effective and meet regulatory standards.

One way FDA works to ensure drug manufacturers comply with CGMP requirements is through inspections. The information below explains the actions FDA takes to accomplish this goal through CGMP inspections that evaluate drug manufacturers’ compliance with CGMP requirements and the actions that can be taken if those manufacturers fail to meet regulatory standards.

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View the webinar on understanding FDA inspections and data for more information. 

How FDA Evaluates and Ensures Compliance

More Information

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ORA Frequently Requested or Proactively Posted Compliance Records: Search publicly available Form FDA 483 inspection findings and other correspondence to FDA-regulated companies located within the U.S. 

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CDER Frequently Requested or Proactively Posted Compliance Records: Search for publicly available Form FDA 483 inspection findings, untitled letters and other correspondence to FDA-regulated companies located within or outside of the U.S.  

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