The Exact Wording on a 483 That Tells You a Warning Letter Is Already Being Drafted

The Cohance Lifesciences Limited Warning Letter breakdown Most QA teams treat the 15-business-day response window as the finish line. Submit on time, check the box, move on. Cohance Lifesciences did exactly that. Their inspection ended August 12, 2025. They submitted their 483 response September 2 – inside the window. Five months later, FDA issued Warning […]

Sato Pharmaceutical Got an FDA Warning Letter.Six Media Fill Failures. Products Still on U.S. Shelves.

FDA issued a Warning Letter to Sato Pharmaceutical Co., Ltd., a Japanese OTC drug manufacturer, on May 18, 2026. I want to be direct about what this letter actually represents before we get into the specifics. This is not a Warning Letter for inadequate procedures or incomplete documentation. This is FDA telling a manufacturer that […]

The Most Controversial Conversation Ever Published inThe Investigator’s Lens

I have published articles that made compliance professionals uncomfortable. Articles that named what most publications in this space are too cautious to name. Articles that generated more direct replies than anything else I have written. This one is different. What you are about to read is the most controversial conversation ever published in The Investigator’s […]

𝐅𝐨𝐫𝐦𝐞𝐫 𝐅𝐃𝐀 𝐈𝐧𝐯𝐞𝐬𝐭𝐢𝐠𝐚𝐭𝐨𝐫𝐬 𝐑𝐞𝐯𝐞𝐚𝐥𝐞𝐝 𝐖𝐡𝐚𝐭 𝐂𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 𝐃𝐢𝐝 𝐓𝐡𝐚𝐭 𝐀𝐜𝐭𝐮𝐚𝐥𝐥𝐲 𝐈𝐦𝐩𝐫𝐞𝐬𝐬𝐞𝐝 𝐓𝐡𝐞𝐦 𝐃𝐮𝐫𝐢𝐧𝐠 𝐚𝐧 𝐈𝐧𝐬𝐩𝐞𝐜𝐭𝐢𝐨𝐧

Most inspection readiness programs are built around the same assumption: if your documents are in order, your CAPA system is current, and your staff is trained, you are prepared. I went back to three of my former FDA Investigator colleagues, combined 40-plus years of field experience between them, and asked each one to describe a […]

The Five Areas Where FDA Investigators Consistently Find the Most Critical Deficiencies

I went back to my three former FDA Investigator colleagues for a second conversation. The first time I asked them how they found deficiencies. This time I asked them where. I spent 14 years as an FDA Investigator myself. Then 13 years as a Quality executive on the industry side. Then 6 years auditing from […]

FDA Has Started 1-Day Unannounced Inspections — And Your Site Could Be Next

This is not a proposal. It is not a pilot that is still being evaluated. It is already happening. In a May 6, 2026 press announcement, FDA confirmed it has been conducting shorter, focused one-day inspectional assessments since April 2026. As of the announcement, approximately 46 assessments had already been completed. Facilities are being selected […]

Three Former FDA Investigators Revealed How They Actually Find What Companies Try to Hide

I asked three former FDA Investigators to do something most would never agree to in a public forum. Tell me the techniques you actually used. Not the official inspection procedure. The specific methods you developed over years in the field that consistently revealed what facilities believed was hidden. They agreed — on the condition I […]

Five Things FDA Investigators Notice Before You Even Sit Down

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 […]

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

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 […]

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

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 […]