Glossary
Out-of-Trend (OOT) Result
A test result that, although within specification, departs from previous results or from the expected statistical trend.
Related sections
21 CFR 211.160–211.194EU GMP Part I Chapter 6
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your firm failed to ensure that aseptic processing areas include floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable (21 CFR 211.42(c)(10)(i)).
FDA · FDA Warning Letter · 2021-11-09 -
Mobile carts used in the setup of (b)(4) units required operators to get down to the floor and manually lock and unlock the cart brakes despite previously determining equipment proximity to the floor as a contributing root…
FDA · FDA Warning Letter · 2025-01-21 -
The video footage shows operators extending their forearms and gloved hands directly over both the sterile stopper tray and open vial tray during stoppering operations in the ISO 5 hood, contradicting your assertion of no obstruction.
FDA · FDA Warning Letter · 2026-05-12
