Contact the Office of Inspections and Investigations

• Report a problem with FDA-regulated products
• Resolve a Dispute
• Find FDA/OII Staff Members
• Stay Informed
• For Industry

Report a problem with FDA-regulated products

If this is an emergency

• If you are experiencing a life-threatening medical emergency, call 9-1-1.
• To report an emergency involving food, drugs, medical devices, dietary supplements, or cosmetics, call 1-866-300-4374 or 1-301-796-8240.

 

By phone: Call 1-888-INFO-FDA (1-888-463-6332).   For more details, see How to Report a Problem

Online: SmartHub Portal to report a product problem Report Suspected Criminal Activity: If you wish to report suspected criminal activity relating to FDA regulated products. MedWatch: Use the MedWatch Online Reporting Form to report adverse events with human food and medical products or call 800-332-1088. To report the unlawful sale of an FDA-regulated medical products on the internet. If the product involves a life-threatening situation call 1-866-300-4374.

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Resolve a Dispute

• Contact the OII Ombudsman

Find FDA/OII staff members

• OII Field Leadership Contacts
• FDA Import Contacts and Office Locations
• OII Recall Coordinators
• Search the HHS employee directory (includes FDA employees)

Stay informed

• Recalls, Market Withdrawals, & Safety Alerts 
• Enforcement Reports
• OII FOIA Electronic Reading Room
• MedWatch: The FDA Safety Information and Adverse Event Reporting Program
• Career Opportunities at the Office of Inspections and Investigations
• Get email updates
• Subscribe to podcasts and news feeds (RSS)
• Follow @FDAInspects on X.com (formerlyTwitter) 

For Industry

• General FDA industry information
• Small Business Assistance
• Import Alerts
• FDA Contacts for Regulatory Partners
• Code of Federal Regulations (CFR)