Reporting Serious Adverse Events for Cosmetics – FDA MoCRA Compliance
Legal background
Accurate and timely reporting of serious adverse events protects consumers and safeguards your brand’s reputation and ensures ongoing U.S. market access. It is essential for maintaining lawful access to the U.S. cosmetics market. Failing to monitor and report serious adverse events can trigger severe regulatory consequences.
Under MoCRA, non-compliance may result in:
-
-
- FDA facility registration suspension
- Product seizures or recalls
- Market withdrawals for affected products
- Brand damage and loss of consumer trust
- Brand damage and loss of consumer trust
-
Our services
How Obelis Supports Your FDA Adverse Event Compliance
As your trusted U.S. Agent or Regulatory Partner, Obelis provides end-to-end support in reporting Serious Adverse Events for cosmetic products under FDA MoCRA. We help you:
- Monitor and collect adverse event data
- Determine whether an event qualifies as “serious” under MoCRA
- Report serious adverse events directly to the FDA within 15 days
- Maintain full documentation for six years in line with FDA requirements
- Advise on corrective actions to mitigate risk and maintain market access
With Obelis, you gain a proactive, compliant system for adverse event handling and peace of mind in case of regulatory audits.
