The Record Behind the Decision
The Podcast for Real GMP Decisions
Conversations with quality and compliance leaders about consequential decisions, the reasoning behind them, and what they mean in practice.
Listen to the Latest EpisodeHosted by Samantha and Alex.
Showing 1 episode on Deviation Closure
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Episode 3 · Deviation Closure
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.
Listen · 21 min 8 sec