Drugs

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

  • 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.
  • Inspection and Enforcement references. This web site from the Office of Regulatory Affairs provides links to Compliance Policy Guides, Regulatory Procedures Manual, the Investigations Operations Manual, and related information. Chapter 4 of the Compliance Policy Guide covers human drugs, and Chapter 1 includes information on multiple commodities regulated by FDA.

Contact for Further Information:

CDER-OPQ-Inquiries@fda.hhs.gov

Page Last Updated: 03/30/2018
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