𝐒𝐢𝐱 𝐐𝐮𝐞𝐬𝐭𝐢𝐨𝐧𝐬 𝐘𝐨𝐮𝐫 𝐅𝐥𝐨𝐨𝐫 𝐒𝐭𝐚𝐟𝐟 𝐖𝐢𝐥𝐥 𝐁𝐞 𝐀𝐬𝐤𝐞𝐝 𝐃𝐮𝐫𝐢𝐧𝐠 𝐚𝐧 𝐅𝐃𝐀 𝐈𝐧𝐬𝐩𝐞𝐜𝐭𝐢𝐨𝐧 (𝐀𝐧𝐝 𝐖𝐡𝐚𝐭 𝐭𝐡𝐞 𝐖𝐫𝐨𝐧𝐠 𝐀𝐧𝐬𝐰𝐞𝐫 𝐂𝐨𝐬𝐭𝐬 𝐘𝐨𝐮)

FDA Investigators do not spend the entire inspection with your Quality Director. At some point, they walk the floor. They talk to line operators, lab technicians, warehouse staff, and QC analysts – people who did not attend the opening meeting, who have not been rehearsed on how to handle an inspection, and who are going […]

𝐒𝐞𝐯𝐞𝐧 𝐓𝐡𝐢𝐧𝐠𝐬 𝐅𝐃𝐀 𝐈𝐧𝐯𝐞𝐬𝐭𝐢𝐠𝐚𝐭𝐨𝐫𝐬 𝐍𝐨𝐭𝐢𝐜𝐞 𝐁𝐞𝐟𝐨𝐫𝐞 𝐓𝐡𝐞𝐲 𝐀𝐬𝐤 𝐟𝐨𝐫 𝐚 𝐒𝐢𝐧𝐠𝐥𝐞 𝐃𝐨𝐜𝐮𝐦𝐞𝐧𝐭

Most companies spend months preparing their documents for an FDA inspection. The reality is that the Investigator has already formed an opinion about your facility before your document coordinator brings out the first record. I spent 14 years as an FDA Investigator and issued more Form 483s than I care to count. For the 13 […]

FDA Investigators Have Already Formed an Opinion About Your Facility Before They Ask for a Single Document.

Most pharmaceutical companies prepare for FDA inspections by preparing their documents. That is the wrong starting point – and experienced Investigators know it the moment they arrive. Here is something the pharmaceutical industry does not talk about enough: an FDA inspection does not begin when the Investigator sits down and requests your batch records. It […]

FDA Caught a Major Drug Supplier Tampering With Batch Records. Again.

When the same pharmaceutical manufacturer receives multiple FDA enforcement actions across multiple facilities in just a few years, it stops being a compliance problem. It becomes a pattern. And patterns tell you something about culture that no corrective action plan can paper over. One of the largest generic drug suppliers to the U.S. market is […]

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 […]