GMP inspection leads to a warning letter for disease claims and GMP violations
Plan for FDA inspections by addressing common violations
GMP inspection leads to a warning letter for disease claims and GMP violations. #WarningLetterWednesday
In this letter, common GMP violations such as setting specifications and the company’s inadequate 483 responses led to the warning letter. Most 483s can be addressed before they become a warning letter. Here’s a recent “GMP Violations & Unanswered 483s Lead to a Warning Letter” post and video about this.
I wrote this very detailed post about GMP pitfalls as a training tool, and I hope you enjoy it.
Learn about the differences between 483s and warning letters here.
Disease claims from the product label and website are mentioned in this letter.
From FDA warning letter. “On your product label: “Take if suffering from glaucoma or ocular hypertension.”
This falls under the “treatment” part of diseases. Remember the DSHEA disclaimer “not intended to diagnose, treat, cure, or prevent disease.”
From FDA warning letter. “Alereve was developed to better treat patients’ ocular allergies without exacerbating their dry eye component in fact, our initial study demonstrated that some patient’s Dry Eye Syndrome was significantly improved with Alereve treatment”
In my opinion, this is added as a “pigpile” or” secondary claim” and would not attract a warning letter unless higher risk claims are present.
Read the warning letter here.
Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.