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September 25, 2025

A male scientist in protective gear participates in a remote FDA inspection via video call with a female inspector on his computer screen, symbolizing the shift to virtual regulatory practices during and after COVID-19.

Inspections

How COVID Changed Remote FDA Inspections—and What It Means for 2025

FDA Inspections Team / September 25, 2025

Person holding an FDA warning letter while preparing a written response at a wooden desk. A laptop, notebook, pen, and a document labeled “RESPONSE” are neatly arranged, symbolizing strategy and timely communication.

Warning Letters

How to Respond to an FDA Warning Letter: Strategy, Timing & Tone

FDA Inspections Team / September 25, 2025

A male professional in a white lab coat reviews an FDA inspection readiness plan on a clipboard in a modern office. Sitting at a wooden desk with a laptop, he writes notes carefully, representing preparation, compliance, and focus on regulatory standards.

Inspections

Building an FDA Inspection Readiness Plan: Steps for a Compliant Facility

FDA Inspections Team / September 25, 2025

Close-up of a person holding a printed "Part 11 Software Validation Checklist" while sitting at a wooden desk. The person holds a pen, ready to check off items. A laptop, spiral notebook, calculator, and documents are arranged neatly, symbolizing compliance planning.

Inspections

Part 11 Software Validation Checklist: Ensure Compliance from Day One

FDA Inspections Team / September 25, 2025

A scientist wearing a lab coat, hairnet, mask, and glasses works on a computer displaying a 3D model of a laboratory. The setting illustrates virtual lab environments supporting GxP compliance in pharmaceutical and biotech industries.

Inspections

GxP Compliance in Virtual Laboratories: Key Challenges and Best Practices

FDA Inspections Team / September 25, 2025

Scientist in a lab coat works on a computer displaying AI graphics, surrounded by test tubes and a microscope in a modern pharmaceutical lab.

Inspections

Using AI in Pharmaceutical Quality Control: Opportunities & Compliance Risks

FDA Inspections Team / September 25, 2025

Close-up of a person holding an FDA warning letter addressed to a medical device company, with a blood pressure monitor and pen on the desk.

Warning Letters

Top Reasons Medical Device Companies Receive FDA Warning Letters

FDA Inspections Team / September 25, 2025

Pharmaceutical worker in protective gear inspecting a tray of tablets inside a clean, sterile GMP-compliant manufacturing facility.

Inspections

A Practical Guide to GMP Compliance for OTC Pharmaceutical Manufacturers

FDA Inspections Team / September 25, 2025

Doctor in a white coat reviews an FDA pre-approval inspection checklist at his desk, holding a pen with focus beside a laptop in an office.

Inspections

FDA Pre-Approval Inspection Checklist: How to Prepare and What to Expect

FDA Inspections Team / September 25, 2025

Person on video call with FDA inspector, holding supplement bottle for virtual inspection, with quality control checklist on desk.

Inspections

What to Expect in Virtual FDA Inspections for Dietary Supplement Facilitie

FDA Inspections Team / September 25, 2025

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FDA Inspections

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