GMP Pitfalls: Marketing, Manufacturing, & Labeling
I got carried away writing this WLW post. Check out my blog for the detailed discussion.
We can learn a lot from warning letters. Following FDA enforcement trends is a valuable tool for any savvy marketer, regulatory affairs professional, quality manager, or dietary supplement executive. We can adjust practices before they elevate to warning letters by learning how to read warning letters and act accordingly.
This is the most detailed Warning Letter Wednesday I have written. Read the full post here.
FDA Inspections Trigger Website Reviews
The company was inspected by FDA in March 2021 and was issued several 483s. The company’s website was recently reviewed in February 2022, which led to a letter. Learn about the difference between a 483 and a warning letter here.
Usually the FDA investigator reviews a company’s website for disease claims before an inspection. That is likely still happening but this is the third recent warning letter where FDA inspections led to a website review at a later date. These website reviews were then elevated to a warning letter. This is an enforcement trend and a reminder for those who have been inspected to clean up website claims.
I write about these letters here.
This warning letter is a great teaching case. Here are the learning targets:
- FDA Inspections Trigger Website Reviews
- Marketing Claims
- Distributors Responsibilities
- Common GMP errors
- Writing and Following Specifications
- Writing Procedures
- Product Returns
- Product Complaints
- Certain Herbs Are Not Allowed
- Common Allergen Labeling
- Domestic Street Address or Phone Number
- Languages Must Contain The Same Information
- Serving Size and Suggested Use
- Plant Parts Must Be Disclosed
- Correct Plant Listing
- Supplement Fact Panel: Line Thickness
- Percent Daily Values Label Requirement
- Expiration Dating
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