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Inspections

An FDA investigator in a white lab coat and glasses looks concerned while pointing at a discrepancy in a messy, handwritten notebook inside a bright, modern pharmaceutical manufacturing facility.

Inspections

Common Documentation Failures Found During FDA Inspections

FDA Inspections Team / April 6, 2026

A male forensic investigator in a white lab coat leans forward, intensely studying a large monitor displaying abstract data logs and audit trails in a clinical pharmaceutical laboratory.

Inspections

What FDA Investigators Look for in Laboratory Records

FDA Inspections Team / April 6, 2026

A male executive in a charcoal suit and a female consultant in a burgundy blazer review a digital compliance dashboard on a tablet while overlooking a pharmaceutical sterile filling line.

Inspections

How Gap Analysis Prevents FDA Enforcement Actions

FDA Inspections Team / April 6, 2026

A male forensic auditor in a lab coat and blue gloves connects a forensic device to a hard drive in a lab. A laptop displays data progress next to a large analytical instrument and tools.

Inspections

How FDA Detects Data Integrity Manipulation in Laboratories

FDA Inspections Team / April 6, 2026

A female regulatory specialist in a charcoal blazer interacts with a large transparent holographic display showing a glowing 3D global network and data charts in a darkened, modern office.

Inspections

FDA Inspection Trends: What Investigators Are Focusing on Now

FDA Inspections Team / April 6, 2026

Five corporate and lab professionals meet around a glass table in a modern, glass-walled factory. A manager stands to speak while colleagues look on. In the blurred background, lab workers and large stainless steel tanks are visible.

Inspections

The Role of the Quality Unit During FDA Inspections

FDA Inspections Team / April 6, 2026

A senior QA director and male legal counsel in formal suits engage in a serious discussion at a black desk in a sleek office, featuring regulatory binders and a city skyline in the background.

Inspections

The 15-Day Rule: Responding to FDA Form 483 Observations

FDA Inspections Team / April 5, 2026

A male QC analyst in a lab coat and mask uses forceps to sample a softgel at a stainless steel workstation featuring a dissolution tester, analytical balance, and monitors with data charts.

Inspections

FDA Inspection Preparation for Food and Dietary Supplement Facilities

FDA Inspections Team / April 5, 2026

A female scientist in a sterile gown and blue gloves pipettes a sample inside a safety cabinet. A monitor shows protein data charts with a blurred bioreactor suite visible in the background.

Inspections

FDA Inspection Preparation for Biologics Manufacturers

FDA Inspections Team / April 5, 2026

A senior female auditor and junior male auditor in white lab coats and hairnets review paper records and a digital tablet at a stainless steel table in a pharmaceutical filing room.

Inspections

How to Conduct an Internal GMP Audit Before an FDA Inspection

FDA Inspections Team / April 5, 2026

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FDA Inspections

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(208) 971-6430
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