Available 24/7 for Urgent On-Site or Virtual Consulting

FDA Inspections

Consulting and Compliance

The United States and European Union will be able to use each other’s Pharmaceutical Inspections

May 26, 2025

You need to be logged in to view this content. Please . Not a Member? Join Us

Latest News and Articles

A validation inspector wearing blue nitrile gloves calibrating an industrial pressure gauge connected to reinforced single-use processing tubes inside a cleanroom.

What Happens During an FDA For-Cause Inspection?

A logistics inspector in gray utility gloves writing on a clipboard to check a shipping manifest and temperature logs at a global container port terminal.

FDA Foreign Inspections Are Increasing Again: What Global Manufacturers Should Expect

A regulatory auditor in gray utility gloves using a rugged mobile tablet to review electronic system audit trails and digital quality data networks inside a pharmaceutical lab.

How FDA Uses AI and Data Analytics During Modern Inspections

A pharmaceutical quality auditor wearing blue nitrile safety gloves executing a surface validation swab on the inner rim of an open stainless steel blending vessel.

The Most Common FDA 483 Observations in Pharmaceutical Manufacturing

A heavy-duty stainless steel chromatography column base connected to clear braided transfer tubes containing clear amber biological harvest fluid within a sterile facility.

How FDA Inspects Viral Vector Manufacturing Facilities

A cleanroom validation technician using a torque wrench to adjust a mechanical valve on an industrial chromatography column unit within a biopharmaceutical plant.

FDA Pre-Approval Inspections (PAIs) for Biologics: Common Readiness Gaps

A corporate compliance director holding a transparent digital glass tablet to cross-reference automated data logs and live facility monitoring streams.

FDA Remote Regulatory Assessments (RRAs): What Biotech Companies Need to Know

A regulatory affairs director and a clinical operator reviewing automated data lineage paths on an interactive luminescent glass panel inside a pharmaceutical facility.

How FDA Investigators Review Batch Records During Drug Inspections

A bioprocess engineer in a full sterile cleanroom suit inspecting single-use bioreactor tubing lines and electronic validation graphs during an mRNA manufacturing facility audit.

How FDA Inspects mRNA and Advanced Therapy Manufacturing Facilities

A corporate regulatory compliance director analyzing global manufacturing data and remote assessment metrics on a transparent digital glass tablet in a high-tech tracking hub.

FDA Inspection Trends in 2026: Biologics, AI, Foreign Facilities, and Remote Assessments

FDA Inspections

Your trusted partner for FDA compliance and inspection readiness. With former ex-FDA’ers on our team, we provide the expertise and confidence you need to succeed.

Services

Industries

© 2024 FDA Inspections. All rights reserved.

THE IMMERSIVE FDA INSPECTION EXPERIENCE →

WARNING LETTERS 483 OBSERVATIONS