Latest insights and updates from Atlas Compliance
tl;dr: FDA warning letters are serious red flags that indicate regulatory non-compliance. If not addressed properly, they can trigger follow-up inspections, damage a company’s reputation, and even lead to product recalls or facility shutdowns. Companies receiving these letters must act swiftly to correct violations, as failure to do so can result in severe penalties, including […]
The United States, particularly the state of New York, recently banned the Chinese artificial intelligence assistant DeepSeek from government devices. The decision, announced by Governor Kathy Hochul, was driven by concerns over national security, censorship, and the risk of foreign surveillance. This move is part of a broader effort by the U.S. to safeguard data […]
The medical device industry is one of the most heavily regulated sectors, ensuring that all products are safe, effective, and meet high-quality standards. In the U.S., the Food and Drug Administration (FDA) oversees these regulations, setting guidelines that manufacturers must follow to bring their devices to market. Understanding these guidelines is crucial for compliance, avoiding […]
tl;dr: In a world where regulatory scrutiny continues to tighten, life sciences companies can’t afford to fall behind on compliance. Whether you’re preparing for an FDA inspection or trying to stay ahead of regulatory trends, one name keeps surfacing among compliance teams: Atlas Compliance. But what exactly is Atlas Compliance, and how can it help […]
FDA AI Draft Guidance – On January 6, 2025, the U.S. Food and Drug Administration (FDA) released a draft guidance titled “Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products.”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 […]
tl;dr: To access FDA inspection reports quickly, explore Atlas Compliance—a leading regulatory inspection intelligence platform. With an extensive database, advanced AI features, and detailed inspector profiles, Atlas ensures life science companies stay ahead in compliance. Download reports, request missing documents, and unlock actionable insights for your business. Streamline Your Compliance: Quickly Access FDA Inspection Reports […]
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 […]