FDA Adverse Event Reporting
When a consumer experiences a negative reaction linked to a regulated product, FDA requires companies to document and report the incident. This process is known as Adverse Event Reporting — and it’s critical to protecting public health and keeping your business compliant.
At USAgentPros, we simplify adverse event reporting for food, dietary supplements, cosmetics, medical devices, and drug products.
Why Adverse Event Reporting Matters
Failing to report adverse events can lead to:
- FDA warning letters and enforcement actions
- Product recalls or market withdrawals
- Damage to your brand’s credibility and consumer trust
Our Adverse Event Reporting Services
- Collecting and documenting consumer complaints and reports
- Submitting required information to FDA
- Tracking and managing follow-up actions
- Maintaining detailed records for inspections and audits
Who Must Report?
Adverse event reporting applies to many FDA-regulated products, including:
- Dietary supplements
- Cosmetics and personal care products
- Medical devices
- Over-the-counter and prescription drugs
Why Cosmetics Brands Choose USAgentPros
Dedicated Compliance Pro – A real expert managing your reporting process
Fast Turnarounds – Timely submissions that meet FDA deadlines
100% Money-Back Guarantee – Confidence with every service
Competitive Pricing – Affordable compliance solutions
Stay Compliant with Adverse Event Reporting
Protect your brand and meet FDA requirements with help from USAgentPros.