250 Weeks of WLW!
GMP & marketing lessons
Celebration! Today is 250 consecutive weeks of this Warning Letter Wednesday® post! Before we get into this week’s post, I think some reflection is in order. I started writing about enforcement trends with more frequency early in the pandemic and found that I, and the LinkedIn audience enjoyed these posts. Back then, FDA’s warning letters dropped on Wednesday, which is where “Warning Letter Wednesday” came from. Thanks to Steven Yeager for helping me come up with this name! I’ve written WLWs while in the Serengeti watching the great wildebeest migration to the sounds of elephants and lions, in remote areas of Laos on the Mekong River, in New Zealand while visiting family, late night at trade shows or while super sick. We plan our dinners around this post to ensure that, directly after dinner, I have a few hours to write. WLW gives me time each week to dig into enforcement trends, which makes me better at my job and gives me the opportunity to continue developing as a regulatory expert. I love it! This has turned into an email newsletter read by thousands in the industry each week and many more on LinkedIn. Thanks for all of your support!
This week’s post has all the greatest hits: GMP violations, improper 483 responses, and website disease claims. These are all great reminders of the importance of compliance.
Here FDA cites many of the basics of an MMR. These are great reminders!
From warning letter. “The Master Packaging Record you provided did not include the following elements of a master manufacturing record required by 21 CFR 111.210:
- Strength and batch size of the dietary supplement [21 CFR 111.210(a)];
- Statement of theoretical yield [21 CFR 111.210(f)];
- Description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)];
- Procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)]; and
- Specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record [21 CFR 111.210(h)(3)].”
Disease claims are mentioned in this warning letter. These are reminders that ingredient claims are fair game for FDA scrutiny.
From warning letter. “It is beneficial to health issues that are related to stress and has a positive effect on those with physical and emotional depression.”
- “Schizandra has also been known to lower blood pressure…”
Improper 483 responses: In many cases, companies can prevent a warning letter with a comprehensive 483 response. Here FDA cites the company for not proving they will test for identity, purity, and composition.
From warning letter. “We have reviewed your November 5, 2025 response to the form FDA 483 which includes documents described by you as finished product specifications … dietary supplements. However, these documents do not demonstrate that you have established the required specifications that will ensure the identity, purity, strength, and composition of the dietary supplements. For example, these documents do not establish strength specifications for each ingredient present in the products or purity.”
Label storage instructions must match the specifications. Here FDA cites the company for not ensuring the label storage instructions match the procedures. Typically, a mock audit should catch these types of oversights.
From warning letter. “The temperature limits…stated in your Holding and Distribution procedure included with your November 5, 2025 response to the Form FDA 483 are inconsistent with the storage requirements (59-86 degrees Fahrenheit) listed on the … product labels collected during the inspection.”
There’s much more to this. I invite you to read the full warning letter.
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