Articles — The Inspection Record

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What Hiring Optimizes For

Batch Release · 21 CFR 211.22 · 211.165 · 211.192

The Batch Record Confirms Execution. It Does Not Capture Judgment.

Batch Release · 21 CFR 211.22 · 211.165 · 211.192

Why Batch Release Fails FDA Inspection After the Lot Has Already Shipped

Batch Release · 21 CFR 211.22 · 211.165 · 211.192

Why Batch Release Fails FDA Inspection After the Lot Has Already Shipped

Editorial · 21 CFR 211.192 · 820.100

The Decision Was Right. The Record Still Failed.

Operations · FDCA Â§503B Â· FDA Bulks List Guidance Â§III.B (April 2026) Â· 21 CFR Â§211.42, Â§211.113, Â§211.192

The 503B Regulatory Cliff: What an Inspector Will Reconstruct After June 29

Editorial · 21 CFR Part 11 Â· FDA AI Guidance Â· GMP Accountability

From Operating System to Intelligence System: What the Shift Means for Quality

Editorial · 21 CFR Part 11 Â· FDA AI Guidance

AI Will Accelerate GMP Operations. The Reasoning Behind Them Will Not Be Reconstructable.

CAPA Effectiveness · 21 CFR 820.100

The CAPA was closed. The effectiveness determination was never authorized.

Batch Release · 21 CFR 211.192

Same atypical result. Same conclusion. One observation. One clean record.

Deviation Root Cause · 21 CFR 211.192

The Inspector Doesn't Ask If You Found the Root Cause. She Asks Who Authorized the Conclusion.