Every Wednesday Asa reviews interesting warning letters and other enforcement trends. He’s been writing this each week for 5 years, and it is a labor of regulatory love.
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This dietary supplement company was inspected by FDA in November and issued 483s and several months later, the FDA reviewed its website and social media. Online disease claims, along with GMP violations, led to this warning letter. Lots of good learning opportunities here. Let’s start ...
5 years of WLW posts! I appreciate you! For five years, every week, I’ve written this newsletter. We plan our ...
FDA just issued a batch of 10 warning letters to companies selling the drug ketamine online. I am still surprised ...
The warning letter covers manufacturing equipment flaws, theoretical yields, incomplete 483 responses, missing product specifications, and other issues. Fun reminders ...
Asa Waldstein is a 24-year veteran of the dietary supplement industry, with experience spanning manufacturing, marketing, and regulatory compliance. He is the principal of Apex Compliance, a software company dedicated to streamlining regulatory marketing compliance for the dietary supplement and natural products sectors. Asa also leads Supplement Advisory Group, a boutique consultancy focused on marketing risk analysis, labeling, and practical compliance strategies for websites and social media. Asa has helped oversee three FDA GMP inspections with no 483s and was honored with the 2023 AHPA Herbal Hero Award and the 2024 What's Up Supps Policy and Change Agent Award. He currently serves as Chair of the American Herbal Products Association’s (AHPA) Technology & AI Innovation Committee.
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