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  5. Inspection | Enforcement Resources
  1. Pharmaceutical Quality Resources

Inspection | Enforcement Resources

  • Inspections Classifications Database
    This database provides final inspection classifications for inspections related to currently marketed FDA-regulated products, including inspections of facilities that manufacture, process, pack, or hold an FDA-regulated product. The classifications are based upon findings identified during an inspection and Agency review for compliance.
  • FDA Data Dashboard
    This dashboard builds on data from resources such as the inspection database, and also provides information regarding compliance actions, recalls, and imports.

Inspection and Enforcement Programs and Guidelines

  • Mutual Recognition Agreement (MRA)
    Under the 2012 Food and Drug Administration Safety and Innovation Act, FDA has the authority to recognize foreign regulatory authorities after determining their capability for conducting drug establishment inspections that meet U.S. requirements.  These Mutual Recognition Agreements (MRAs) allow FDA to rely upon information from drug establishment inspections conducted by recognized foreign authorities.

  • Compliance Programs
    These programs and instructions are for FDA staff, primarily investigators and compliance officers, when conducting and evaluating routine types of inspections, like CGMP inspections. Compliance Programs also provide guidelines for agency staff evaluating significance of violations, and may provide instructions for sampling regulated articles.
  • Inspections, Compliance, Enforcement, and Criminal Investigations
    This webpage provides links to Compliance Manuals, Compliance Actions and Activities, Inspection References, and Criminal Investigations.  The Investigations Operations Manual is the primary operational reference for FDA investigators and other field employees.  Within the Compliance Policy Guide  Chapter 1 includes information on multiple FDA-regulated commodities and Chapter 4 covers human drugs.

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