Warning Letter Wednesday Posts

This company received 483s for GMP violations relating to testing methods and specifications.  They were inspected in late 2021 and early 2022 and sent FDA five 483 responses last year. ...

More overt COVID claims are cited in this warning letter. We all know that making COVID claims about supplements is wrong, but let’s explore key learning lessons you can apply ...

This warning letter involves claims made in catalogs and product labels collected during a GMP inspection. Over 500 supplement executives and regulatory professionals receive Warning Letter Wednesday by email. Sign ...

Digestive system claims like Crohn’s and IBS occasionally show up in warning. Diseases like Crohn’s Disease or syndromes like Irritable Bowel Syndrome should be removed, or if accurate, replaced with ...

Warning Letter Wednesday primarily focuses on FDA-related enforcement, but occasionally I review interesting FTC actions. Today’s #WarningLetterWednesday highlights three FTC cases against distributors of doTerra essential oils and supplements. doTerra ...

This letter primarily cites digestive ailment claims such as Irritable Bowel Syndrome (IBS) and heart health claims such as “lowers cholesterol.” While these types of statements should be avoided, they ...

Claims made about animal products seem to have a lower tolerated “acceptance level” than human products. This is a friendly reminder to take another look at your animal product marketing ...

FDA continues to issue more warning letters to companies that do not adequately respond to 483 violations. The violations and 483 responses provide excellent learning opportunities. Here are some key ...

We can learn a lot from warning letters. This manufacturer was inspected in April 2022, where they received some 483s. The company subsequently responded to some 483s, but according to ...

FDA sent five warning letters this week to companies selling products for Monkeypox. This is a clear violation, but there are some critical learning lessons here. Sign up for the ...

This warning letter resulted from a GMP inspection and label review. Several labeling errors are cited in this letter, which are excellent learning lessons. FDA has clear requirements for nutrient content claims ...

FDA has issued two drug-spiked product warning letters this year! This is the type of action I appreciate seeing the FDA do, as this small number of bad actors in ...