FDA AI Draft Guidance – On January 6, 2025, the U.S. Food and Drug Administration (FDA) released a draft guidance titled “Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products.” This document outlines the types of information the FDA may require when evaluating the use of Artificial Intelligence […]
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 steps
FDA 483 Observations are projected to rise in 2025 due to increased regulatory scrutiny, evolving compliance standards, and a surge in inspections post-pandemic. Companies must prioritize compliance by implementing robust quality systems, conducting regular audits, and addressing issues proactively. Failure to comply can lead to Warning Letters, tarnished reputations, and operational halts. Prevention lies in
The U.S. Food and Drug Administration (FDA) has established January 1, 2028, as the uniform compliance date for all new food labeling rules finalized between January 1, 2025, and December 31, 2026. This decision aims to facilitate a smoother transition for the food industry and reduce economic burdens. What Does This Mean? The uniform 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
