You've Been Warned: FDA Warning And Untitled Letters


Just as you are taking the first sip of your second cup of coffee, the mail arrives, and you catch a glimpse of FDA letterhead. Certain that the FDA has finally approved the NDA for your company’s breakthrough drug or has authorized that critical clinical trial, you abandon your cup of joe, snatch the letter from the pile, and begin skimming the text. Unfortunately, before you make it through the first sentence, you realize that this letter is not the harbinger of good news. Instead, the FDA has paid you an unannounced visit and delivered a rude surprise. Yes, you’ve been warned.

I. Warning Letters And Untitled Letters

The FDA uses two different types of correspondence to warn of regulatory violations — the aptly named “Warning Letter” and the oddly titled “Untitled Letter,” sometimes referred to as a notice of violation letter. While Warning Letters and Untitled Letters are frequently grouped together or confused (often by the press and internet bloggers rushing to draw attention to a company’s violations), the letters convey distinct messages and impose different burdens on the recipient.

Warning Letters are the FDA’s “principal means of achievingprompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act” and are issued for significant regulatory violations. “Significant violations” are “violations that may lead to enforcement action if not promptly and accurately corrected.” Warning Letters can vary in form and style, but all Warning Letters share the following elements...

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