Day: May 12, 2026

Inspections

How FDA Inspects SaMD and AI-Enabled Medical Device Companies
ByFDA Inspections Team May 12, 2026

As artificial intelligence reshapes the medical technology landscape, navigating an AI medical device FDA inspection requires a specialized approach to software validation and algorithmic transparency. This 2026 guide examines how investigators evaluate Software as a Medical Device (SaMD), the importance of Predetermined Change Control Plans (PCCP), and the critical steps for maintaining a state of perpetual audit readiness in a digital-first era.

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News

FDA Cosmetic Facility Inspections Under MoCRA: What to Expect
ByFDA Inspections Team May 12, 2026

The Modernization of Cosmetics Regulation Act (MoCRA) has fundamentally altered the regulatory landscape for the beauty industry. As we enter 2026, cosmetic facilities must prepare for a new era of federal oversight. This guide details what investigators prioritize during MoCRA FDA inspections—from mandatory adverse event reporting to Good Manufacturing Practices (GMP) and safety substantiation—to ensure your facility remains compliant.

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Inspections

High-Traffic Strategic Topics NAI, VAI, and OAI Explained: Understanding FDA Inspection Classifications
ByFDA Inspections Team May 12, 2026May 12, 2026

Every regulatory audit concludes with a critical final assessment that determines the future of a manufacturing site. This 2026 guide provides an expert breakdown of NAI, VAI, and OAI FDA inspection classifications. Understanding these outcomes is essential for maintaining market access, protecting brand reputation, and navigating the increasingly complex world of life sciences compliance.

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Inspections

Top FDA Inspection Findings for Biologics Manufacturing Facilities
ByFDA Inspections Team May 12, 2026May 12, 2026

As the production of complex large-molecule therapies scales globally, navigating the regulatory hurdles of an audit has never been more challenging. This 2026 guide analyzes the most frequent biologics FDA 483 observations, covering critical areas such as environmental monitoring failures, inadequate viral clearance, and data integrity gaps to help manufacturers maintain a state of constant audit readiness.

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Inspections

FDA Inspection Trends for Sterile Injectable Manufacturing in 2026
ByFDA Inspections Team May 12, 2026

As the pharmaceutical industry moves toward advanced aseptic technologies, navigating a sterile manufacturing FDA inspection in 2026 requires a specialized focus on contamination control and automated integrity. This guide explores the latest audit trends—from the impact of Revised Annex 1 to the rise of robotic filling lines—ensuring your facility maintains the highest level of sterility assurance and audit readiness.

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Inspections

Top FDA Inspection Risks for Contract Medical Device Manufacturers
ByFDA Inspections Team May 12, 2026May 12, 2026

Navigating a medical device contract manufacturer FDA inspection requires a rigorous alignment between sponsor expectations and facility operations. As we move into 2026, the risks associated with outsourced manufacturing—ranging from purchasing controls to technical documentation gaps—have intensified. This guide identifies the top inspectional risks and provides a blueprint for maintaining a state of perpetual audit readiness.

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FDA Inspections

Consulting and Compliance

Day: May 12, 2026

How FDA Inspects SaMD and AI-Enabled Medical Device Companies

FDA Cosmetic Facility Inspections Under MoCRA: What to Expect

High-Traffic Strategic Topics NAI, VAI, and OAI Explained: Understanding FDA Inspection Classifications

Top FDA Inspection Findings for Biologics Manufacturing Facilities

FDA Inspection Trends for Sterile Injectable Manufacturing in 2026

Top FDA Inspection Risks for Contract Medical Device Manufacturers

FDA Inspections

Services

Industries