Adverse Events Reporting 

Safeguarding Your Compliance and Reputation

Stay Compliant with Confidence: Effective management of adverse events and recalls is critical for maintaining compliance with MoCRA regulations.

Our team of experts is dedicated to helping you develop and implement robust procedures for reporting adverse events and handling mandatory recalls associated with your cosmetic products.

Why It Matters – Accurate reporting and handling of adverse events are essential for regulatory compliance and protecting your brand. Adverse events may include any negative effects experienced by consumers using your products, and proper management is required by the FDA.

How We Can Help: 

  1. Procedure Development
    • Create clear, efficient procedures for reporting adverse events and managing recalls.
    • Ensure immediate and detailed documentation of events and recalls.
  2. Training and Preparation
    • Train your team on regulatory requirements and procedure execution.
    • Prepare and maintain records required by the FDA.
  3. Recall Management
    • Develop strategies for effective recall execution.
    • Coordinate the company with the FDA and evaluate recall effectiveness.

FDA enforcement has begun. Ensure you have the right procedures and training in place to avoid compliance issues and protect your brand.

Let us guide you through the complexities of adverse events reporting and recall management to ensure MoCRA compliance and safeguard your products and reputation.