Atlas Compliance Blog

tl;dr: FDA Form 483 observations highlight GMP non-compliance during FDA inspections. Common issues include equipment, documentation, processes, training, and facility controls. Prevent them through proactive management, strong documentation, training, audits, and compliance tools. Atlas simplifies compliance by automating insights and improving inspection readiness. What Is FDA Form 483 Observations?  FDA Form 483 observations are official […]

tl;dr: Unexo, an over-the-counter drug manufacturer, recently faced scrutiny during an FDA inspection conducted from May 1, 2024, to May 14, 2024, led by inspectors Nicole Knowlton and Kellia Hicks. This inspection led to the Warning Letter by the USFDA ranging from inadequate documentation to improper facility maintenance. This article breaks down the key observations […]