Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Pharmaceutical Quality Resources

Pharmaceutical Quality Resources

                        Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program
          Search for Pharmaceutical Quality Documents
          Current Good Manufacturing Practice (CGMP) Regulations
          CDER Quality Management Maturity
          Q&A on CGMP Requirements
          Inspection | Enforcement Resources
          Questions and Answers on Quality-Related Controlled Correspondence Home
          Drugs
          Development & Approval Process | Drugs
          Pharmaceutical Quality Resources
          Inspection | Enforcement ResourcesPharmaceutical Quality Resources Inspection | Enforcement Resources
  
  	
    Share
    Post
    Linkedin

    Email
    PrintInspections 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.Contact for Further Information

CDER-OPQ-Inquiries@fda.hhs.gov

                                                                                  Content current as of:
      11/03/2023
              
              
Regulated Product(s)
		 DrugsPharmaceutical Quality Resources

          
                        Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program
          Search for Pharmaceutical Quality Documents
          Current Good Manufacturing Practice (CGMP) Regulations
          CDER Quality Management Maturity
          Q&A on CGMP Requirements
          Inspection | Enforcement Resources
          Questions and Answers on Quality-Related Controlled Correspondence
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop