Inspection Scenarios
Which decision
has your name on it?
FDA investigators isolate one decision and go deep. Each scenario below reflects the exact question they ask — and the record most organizations cannot produce.
Select the scenario that matches your exposure
Each page shows the inspector question, explains why existing documentation typically fails it, and links directly to the $149 case file.
Deviation
Deviation Continuation
"Show me who authorized continued processing after this deviation and what evidence they relied on."
Get the Case File — $149 Batch Release Batch Release Authorization
"Who authorized final release of this batch and what disposition evidence did they review?"
Get the Case File — $149 CAPA CAPA Closure
"Who determined this CAPA was effective and what effectiveness evidence did they review before closure?"
Get the Case File — $149 Change Control Change Control Filing Determination
"Who made the determination on this change's filing pathway and what regulatory basis governed that decision?"
Get the Case File — $149 OOS Investigation OOS Investigation Closure
"Who authorized closure of this OOS investigation, what evidence supported the root cause conclusion, and how was the disposition decision justified?"
Get the Case File — $149 All 10 Case Files
Need a different scenario?
Browse all 10 decision-specific case files — process validation, data integrity, supplier qualification, stability OOT, complaint investigation, and more.
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