tl;dr: FDA inspections are not just regulatory checkpoints — they are critical evaluations of your quality systems, documentation, and risk posture. Whether it’s a routine inspection, a for-cause audit, or a pre-approval inspection, here are 100 essential elements that FDA inspectors often review in the FDA compliance checklist. 1–20: Data Integrity & Documentation (21 CFR […]
In the life sciences industry, product quality and regulatory compliance are non-negotiable. When deviations occur, organizations must act quickly and effectively—not just to fix the issue but to ensure it never happens again. This is where CAPA comes into play. In this definitive 2025 guide, we’ll break down everything you need to know about CAPA,
In 2025, the Center for Biologics Evaluation and Research (CBER) approved a series of groundbreaking biological products and devices, each contributing to advancements in healthcare and patient safety. Below is an overview of notable approvals and regulatory developments during this period. Biological License Application (BLA) Approvals Automated C3d Plate (Anti-Human Globulin, Murine Monoclonal) Noteworthy BLA
The medical device industry operates under strict regulatory oversight to ensure product safety and effectiveness. The U.S. Food and Drug Administration (FDA) is pivotal in establishing and enforcing compliance standards. In 2023 alone, the FDA issued over 1,200 warning letters related to medical device compliance, highlighting the increasing scrutiny of manufacturers. Staying informed about these
In today’s highly regulated pharmaceutical landscape, staying ahead of compliance issues is critical. Regulatory inspections and enforcement actions can significantly impact operations, product approvals, and market confidence. That’s where Atlas comes in—an advanced FDA inspection intelligence platform that provides real-time notifications on inspections and regulatory events, ensuring manufacturers are always informed and prepared. Why do
For pharmaceutical, biotech, and medical device companies, FDA inspections are a critical part of regulatory compliance. One of the most valuable ways to prepare for an inspection is by understanding the background and focus areas of the specific FDA investigator assigned to your facility. But is it possible to search for specific FDA investigators and
For pharmaceutical, biotech, and medical device companies, FDA inspections are critical to ensuring product quality, regulatory compliance, and market access. However, preparing for an FDA inspection can be daunting, requiring companies to navigate complex regulations, analyze past inspection trends, and proactively address potential compliance gaps. This is where Atlas, an advanced FDA inspection intelligence platform,
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
