Ensuring consumer safety is at the core of FDA regulations, and one of the most critical obligations for companies in the food, dietary supplement, cosmetic, and OTC product industries is adverse event and safety reporting. The FDA requires manufacturers, packers, distributors, and importers to maintain systems for documenting and reporting serious adverse events linked to their products. Non-compliance can result in warning letters, product recalls, and regulatory enforcement.

A serious adverse event is defined as any health-related incident such as hospitalization, significant injury, disability, or death associated with product use. Companies must submit reports to the FDA promptly and maintain supporting safety documentation for audit readiness. This process ensures transparency, protects public health, and builds consumer trust.

Key requirements under FDA adverse event reporting include:

• Mandatory Reporting – Serious adverse events must be submitted to the FDA within strict timelines.
• Safety Recordkeeping – Firms must maintain records for at least six years (depending on product category).
• Consumer Complaint Handling – Proper intake, evaluation, and categorization of complaints.
• Audit-Ready Documentation – Records must be readily available for FDA inspection or request.
• MoCRA & Dietary Supplement Rules – Cosmetics now require adverse event reporting under MoCRA, while supplements follow the Dietary Supplement and Nonprescription Drug Consumer Protection Act.

At XPRO America, we help businesses establish and manage FDA-compliant adverse event reporting systems. Our services include:

• Complaint Intake & Evaluation Systems – Structured handling of consumer feedback.
• FDA Submission Support – Preparation and filing of adverse event reports.
• Safety Record Management – Creating audit-ready documentation.
• Training & Monitoring – Ensuring staff are prepared to meet ongoing reporting obligations.

With FDA scrutiny intensifying across industries, companies must be proactive in monitoring product safety and reporting adverse events. XPRO America provides the expertise and compliance support needed to protect your brand, meet regulatory obligations, and ensure smooth market access.

XPRO America provides FDA-compliant adverse event & safety reporting services, ensuring audit-ready records, timely FDA submissions, and regulatory compliance.