Published
April 6
2026
2026
Batch Release · 21 CFR 211.192
Same atypical result. Same conclusion. One observation. One clean record.
Live
April 8
2026
2026
CAPA Effectiveness · 21 CFR 211.192
The CAPA was closed. The effectiveness determination was never authorized.
Coming April 8
April 10
2026
2026
OOS Investigation · 21 CFR 211.192
The result was explained. The invalidation was never authorized.
Coming April 10
April 14
2026
2026
Deviation · 21 CFR 211.192
The deviation closed. The authorization question didn't.
Coming April 14