Warning Letter Wednesday^® Posts

This company was inspected by FDA and received several common 483 violations, such as improper specifications and not having written procedures for cleaning and product returns. From my reading of ...

FDA has been paying close attention to probiotic products marketed to preterm infants recently, and this letter shows the continuing trend. There are ~100 searchable Warning Letter Wednesday posts here! You can ...

This warning letter is interesting as it details some of FDA’s thinking on test methods. Upon my initial reading of this letter, it seemed like FDA had an issue with ...

Listing herbal ingredients on labels in the correct format is important. This year, there have been seven warning letters that reference missing or incorrect standardized common names (SCN) on labels. ...

This company was cited for making high-risk claims related to colds, the flu, and viruses in product and ingredient descriptions. This warning letter is an excellent lesson on what not ...

This warning letter cites a kratom company for making disease claims related to opioid withdrawal, cancer, and depression in blogs. The learning targets in this Warning Letter Wednesday are: 1) ...

When FDA asks for records, companies should generally comply or they can face warning letters. This year FDA has sent eight warning letters to OTC companies refusing to respond to ...

This company is a small manufacturing facility and storefront that is reminiscent of the companies I would order herbs from in the 1990s. Since then, herbal regulations have matured, but ...

Eight companies received warning letters for selling homeopathic and other eye-lubricating products. This signals the continued shift in FDA’s enforcement priorities towards homeopathics. Most of these companies were selling ophthalmic ...

This company received several observations for minor labeling issues, but the GMP-related observations and the website disease claims likely tipped the scale into a warning letter. This warning letter is ...

Amazon, Walmart, and four other companies were issued warning letters for distributing homeopathic products used to treat molluscum contagiosum, a viral skin condition most commonly occurring in children. This is the second ...

This Traditional Chinese Medicine (TCM) product company was cited for GMP violations and disease claims. This warning letter contains critical GMP and marketing lessons such as labeling, testing, and marketing ...