Preparing for and undergoing an FDA inspection can be a daunting process for companies, especially those operating in highly regulated industries such as pharmaceuticals, medical devices, and food production. Despite their best efforts, many companies make mistakes during FDA inspections that can lead to warning letters, fines, or even product recalls. Below, we highlight the […]
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In the life sciences industry, maintaining compliance with regulatory bodies like the FDA is not just a responsibility; it’s a necessity. Companies must meet stringent standards to ensure their products are safe, effective, and manufactured in controlled conditions. However, navigating these compliance requirements can often feel like walking through a maze. That’s where Atlas Compliance
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
