Articles — The Inspection Record

Published

Operations · FDCA §503B · 21 CFR 211.42

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

Editorial · 21 CFR Part 11 · 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.

OOS Investigation · 21 CFR 211.192

The result was explained. The invalidation was never authorized.

Deviation · 21 CFR 211.192

The deviation closed. The authorization question didn't.

Deviation Root Cause · 21 CFR 211.192

The inspector doesn't ask if you found the root cause. She asks who authorized the conclusion.

Batch Release · 21 CFR 211.192

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