GMP Pitfalls: Marketing, Manufacturing, & Labeling

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 why I write the weekly Warning Letter Wednesday post on LinkedIn, Twitter, and Facebook. This blog post is an extended version of my Warning Letter Wednesday posts.

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</