← The Record Behind the Decision
Episode 3 · Deviation Closure · 21 min 8 sec
The Deviation Was Closed. The Problem Wasn't.
Samantha and Alex examine two FDA warning letters from September 2026, Fresenius Kabi and Baxter, and the deviation closures that looked complete until FDA read them.
With Samantha and Alex ·
What did this episode raise for you?
Ask about this episode or your situation…
“We closed a deviation after retraining the operator. What would show the closure reasoning holds up?”
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Examine the decision
Deviation Closure Case File
A signed closure shows that a deviation was closed. The Case File shows what that decision needs to preserve: the evidence, the root-cause judgment, the risk left open, and who had the authority to close it.
Examine the Case File — $149Working on your own deviation? View the Deviation Decision Check — $39
The Decision Tool is a structured review of your own records. It is not a compliance determination, does not make, approve, or authorize a regulated Quality decision, and does not predict inspection outcomes.
Further reading
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Article · 7 min read
The second person’s check line is blank. What establishes that the check happened?
Someone credible says a colleague looked at the label. The line for that person is blank. Presence, plausibility and a trusted voice are all consistent with a check. Only one kind of evidence is a record of one.
Read the article -
Article · 7 min read
A record entry is missing. Was the work not written down, or not done?
A missing entry can mean someone forgot to write down work they did. It can also mean the work was not done. Before choosing retraining, Quality has to decide which of those the surrounding records support.
Read the article -
Next episode · Episode 4
How Do We Know It Worked?
Samantha and Alex examine what a CAPA closure has to prove, and why a signed task list is not proof.
Listen · 21 min 1 sec