Author name: Shalu

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Why did the USA ban Deepseek?

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 […]

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Understanding FDA’s Guidelines for Medical Device Manufacturers

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

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Top 10 Questions About Atlas Compliance

tl;dr: Atlas Compliance is an advanced regulatory intelligence platform designed for life sciences companies to stay ahead of FDA inspections. It provides access to a vast repository of FDA 483s, AI-driven insights, and global regulatory data. Key features include smart search, comparative analysis, real-time updates, and investigator profiling. Whether you need to track inspections, respond

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AI Drug Development: FDA Releases Draft Guidance

FDA AI Draft Guidance – On January 6, 2025, the U.S. Food and Drug Administration (FDA) released a draft guidance titled “Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products.”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

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What are common mistakes to avoid during FDA inspections?

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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How to Access FDA Inspection Report Quickly?

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

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What Is Atlas Compliance, and How Does It Help Life Science Companies?

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

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Why FDA 483 Observations Will Be on the Rise in 2025?

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

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How to Address and Prevent FDA Form 483 Observations?

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

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