Most pharmaceutical companies spend months preparing for an FDA inspection. SOPs reviewed. Batch records organized. Staff trained. And then an Investigator walks in unannounced on a Tuesday morning and the first thing they notice has nothing to do with any of it. I spent 14 years as an FDA Investigator. I have walked into hundreds […]

Read More Five Things FDA Investigators Notice Before You Even Sit Down

In March 2026, FDA issued a Warning Letter to Novo Nordisk Inc. following an inspection that concluded in February 2025. Most compliance teams will read this letter and focus on the specific observations. That is the wrong way to read it. I spent 14 years as an FDA Investigator. I wrote 483s. I conducted follow-up […]

Read More Novo Nordisk Just Got an FDA Warning Letter — Here Is What It Actually Means

Most FDA inspection failures are not technical. The deficiencies get written up, sure. But what turns a manageable inspection into a Warning Letter situation is almost always behavioral. I spent 14 years as an FDA Investigator. I walked into hundreds of facilities. I wrote the 483s. I filed the Establishment Inspection Reports that determined whether […]

Read More How to Piss Off an FDA Investigator (And What It Costs You When You Do)