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Warning Letters Manufacturers Compliance

Wiley Rein LLP

Wiley Consumer Protection Download (July 15, 2025)

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FTC Sends Warning Letters Regarding Potential Noncompliance With “Made in USA” Requirements. On July 8, the FTC sent letters to a flagpole retailer, footwear maker, football equipment company, and personal care products...more

Arnall Golden Gregory LLP

I Don’t Want Your Photograph: Actually, FDA Might Want to Take Photographs During an Inspection

While the authors are not huge fans of the rock band Def Leppard, its 1983 “Photograph” hit came to mind recently, when we read a recent Warning Letter issued, in part, because of a company’s refusal to allow photographs...more

Gardner Law

FDA Issues Numerous Warning Letters

Gardner Law on

The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

Alston & Bird

FDA Issues Draft Guidance on Post-Warning Letter Meeting Requests Under GDUFA

Alston & Bird on

On September 1, the Food and Drug Administration issued draft guidance for post-warning letter meeting requests under the Generic Drug User Fee Amendments. Our FDA Compliance & Enforcement Team outlines factors drug...more

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