An Establishment Inspection Report is created after FDA investigators inspect facilities involved in manufacturing, processing, or distributing FDA-regulated products. More than just a summary, the EIR is a critical tool used by both the FDA and regulated entities to assess compliance, address operational risks, and implement meaningful improvements. In this article, we’ll explain everything you […]
Facing an FDA inspection? For businesses in regulated industries such as pharmaceuticals, medical devices, or food production, that moment can define compliance success or expose critical gaps. Long before warning letters are issued, the FDA flags violations through Form 483 observations, formal reports that highlight non-compliance discovered during inspections. In FY 2024 alone, the FDA
Quality Assurance (QA) teams are the silent guardians of compliance in regulated industries. Yet, many organizations overlook the key metrics that reflect not just product quality but regulatory readiness. This article explores essential QA compliance metrics, their strategic value, and how modern tools like Atlas Compliance can bridge the gap between reactive and proactive compliance.
Getting hit with an FDA Form 483 should be a wake-up call. As these observations are often made public, your company is under a tangible risk of losing reputation and consumer trust. An effective response is critical at this stage, as failure can lead to product approval suspensions and delays that impact revenue as well
In the pharmaceutical industry, even minor oversights can lead to significant compliance failures. The Corrective and Preventive Actions (CAPA) process is essential in mitigating these risks and forms the backbone of a robust Quality Management System (QMS). However, many pharmaceutical manufacturers still struggle with effective CAPA implementation. FDA inspection data reveals that inadequate or missing
In pharma, compliance is essential for your business. When the FDA conducts inspections, being unprepared is not only risky but also costly. The FDA conducts around 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries. Many of these inspections result in Form 483s and warning letters, often due to avoidable
Understand the key elements of GxP compliance to help ensure product safety, stay aligned with regulations, and avoid costly penalties in the life sciences sector.
Pharmaceutical regulatory compliance is a critical and growing part of the industry. The U.S. pharmaceutical regulatory affairs market is expected to reach over $2.4 billion by 2030, growing steadily at nearly 8% annually from 2024. This growth highlights how important it is for pharmaceutical companies to manage compliance, both to meet strict safety standards and
tl;dr: FDA inspections are not just regulatory checkpoints but 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 Part 11
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
