FDA Warning Letters

This one is OTT. FDA inspected a South Korean drug manufacturer and found major GMP violations, including some alleged falsified records issues. From warning letter. “Pages were removed from your logbook and ...

“#1 Best Selling Brand” is a bold statement to make. In this case, the National Advertising Division (NAD) helps clarify what this means and how to substantiate it. One of ...

I love puffery. In advertising, puffery is described as an exaggerated, boastful, or subjective promotional claim about a product or service that a reasonable consumer would not take as a ...

FDA inspected this supplement manufacturer and marketer in November 2025 and issued some 483s related to sanitation and GMP documentation issues. The company then sent four 483 responses to FDA ...

I often use this example to explain how FDA enforcement works. A single disease-type claim is unlikely to trigger a warning letter unless it is over the top. Instead, FDA ...

This dietary supplement company was inspected by FDA in November and issued 483s and several months later, the FDA reviewed its website and social media.  Online disease claims, along with ...

5 years of WLW posts! I appreciate you! For five years, every week, I’ve written this newsletter. We plan our Tuesday dinners around this post, as we always know that ...

FDA just issued a batch of 10 warning letters to companies selling the drug ketamine online. I am still surprised when I see drugs openly sold via standard e-commerce, and ...

The warning letter covers manufacturing equipment flaws, theoretical yields, incomplete 483 responses, missing product specifications, and other issues. Fun reminders of the importance of GMP compliance. First, the manufacturing equipment ...

Today’s WLW mentions claims in TikTok Shop, another Amazon letter, and a “disease-oriented” warning letter that does not include high-risk disease claims. Oye vey! When I read this next warning ...

Any product marketed online is “fair game” for FDA enforcement. In this warning letter, a dietary supplement company was cited for making disease claims. Let’s see what we can learn. ...

Everyone uses AI, and in many cases it is wonderful. However, this warning letter highlights that using AI is not a shortcut for quality and reinforces the “trust but verify ...