The SafetyCall Blog

When a manufacturing deviation, product defect, or adverse event pattern raises questions about consumer or patient safety, companies need a structured, scientifically defensible way to assess the risk. A Health…

For the 16th time, SafetyCall International has been named a Minnesota Star Tribune Top Workplace. Behind everything we do, there are real people. A real person answers every call that…

May 8, 2026  | Dietary Supplement Adverse Event Reporting Under DSHEA TLDR: Key Takeaways The Dietary Supplement and Nonprescription Drug Consumer Protection Act requires manufacturers, packers, and distributors whose name…

April 29, 2026  | Cosmetic Adverse Event Reporting Under MoCRA TLDR: Key Takeaways The Modernization of Cosmetics Regulation Act (MoCRA) requires the designated “Responsible Person” for a cosmetic product to…

April 16, 2026  | FDA Adverse Event Reporting Services: A Step-by-Step Process Guide When a reportable adverse event reaches your organization, the first question is: how much time do you…

April 16, 2026  | Adverse Event Management Services: Comprehensive FDA Solutions for Regulatory Compliance TL;DR, Key Takeaways Adverse event (AE) management is a regulatory requirement... Reporting timelines vary by product…

March 11, 2026  |  FDA Announcements, Adverse Event Reporting On March 11, 2026, the FDA officially launched the Adverse Event Monitoring System (AEMS), a unified platform designed to consolidate the…

The U.S. Food and Drug Administration (FDA) today published draft guidance clarifying its authority to access and copy cosmetic company records under the Modernization of Cosmetics Regulation Act of 2022…

In the complex landscape of product manufacturing and regulatory compliance, quality deviations represent significant business and, in some cases, public health challenges. When manufacturing or other product related safety anomalies…