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Welcome to Warning Letter Wednesday®

A weekly exploration of FDA warning letters and enforcement trends

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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Current Post August 26, 2026
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GMP Inspection Surfaces Alleged Record Falsification

Following good documentation practices is a cornerstone of compliance

This one is OTT. FDA inspected a South Korean drug manufacturer and found major GMP violations, including some alleged falsified records issues. From warning letter. “Pages were removed from your logbook and replaced with newly fabricated pages. Your microbiology team leader admitted to using a knife to ...

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Asa Waldstien the author of Warning letter Wednesday

Who is Asa Waldstein?

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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