GMP inspection intelligence for professionals who need to know what actually matters
Every FDA 483 and Warning Letter, analyzed from an operator perspective. No regulatory theater. No vendor influence. Just the signal.
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Every FDA drug manufacturing inspection finding since 2023
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What You Get
Weekly 483 Analysis
Every new Form 483 observation, broken down by what actually happened, why it became a finding, and what to check in your own operation.
Warning Letter Deep Dives
Full examination of FDA Warning Letters with focus on the inspection pattern, escalation triggers, and downstream operational impact.
Quarterly Trend Reports
Pattern analysis across hundreds of inspections. What's rising, what's declining, and what it means for your compliance strategy.
Sample Analysis Excerpt
Why Hold Times Keep Triggering FDA 483s
The issue isn't missing data. It's non-representative data.
The FDA keeps citing the same hold time issue. Companies have the studies. They have the data. The problem? The data doesn't match what actually happens in production.
A Mid-Atlantic CDMO completed a full hold time study for their equilibration buffer. The study documented 72hr stability at 2-8°C, properly approved. On paper, everything looked fine.
The investigator pulled six months of batch records during the inspection. A pattern emerged immediately: the buffer was sitting at RT for 4-6 hours during shift changes, sometimes longer on weekends when the second shift was short-staffed.
The study? It only covered refrigerated storage. They had zero RT data.
What The FDA Actually Cited
Here's how the FDA wrote it up (near-verbatim from three different 483s):
"Your firm failed to establish an adequate hold time study for [material] as the study did not encompass the conditions and duration observed during routine manufacturing operations."
Notice the phrase "routine manufacturing operations." They're not citing you for one-off events. They're citing you for what you do regularly.
This is an excerpt. Full analysis includes three common scenarios, inspection breakdown table, and specific steps to align your studies with actual production conditions.
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