Warning Letters

The latest news, analysis and updates on Warning Letters

Umbrella – Warning Letter

This warning letter, issued on May 18, 2021, addresses concerns about this company’s marketing of kratom and other pharmaceutical and nutritional supplement products. The letter outlines

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Revibe, Inc. – Warning Letter

This document examines the FDA warning letter issued to Revibe, Inc. on May 18, 2018, highlighting the regulatory concerns raised regarding the company’s marketing and manufacturing

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KratomNC – Warning Letter

On May 16, 2019, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to KratomNC, highlighting significant concerns regarding the marketing and safety of

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Umbrella – Warning Letter

This warning letter, issued on May 18, 2021, addresses concerns about this company’s marketing of kratom and other pharmaceutical and nutritional supplement products. The letter outlines

The Golden Road Kratom – Warning Letter

On May 15, 2020, the U.S. Food and Drug Administration (FDA) issued a warning letter to The Golden Road Kratom regarding violations related to the marketing

Shot of Joy LLC – Warning Letter

This document serves as a formal warning issued to Shot of Joy LLC on September 25, 2023, addressing concerns related to non-compliance with regulatory standards and

Revibe, Inc. – Warning Letter

This document examines the FDA warning letter issued to Revibe, Inc. on May 18, 2018, highlighting the regulatory concerns raised regarding the company’s marketing and manufacturing

Mitra Distributing Inc. – Warning Letter

This warning letter, issued to Mitra Distributing Inc. on September 4, 2018, addresses compliance issues identified during a recent inspection. The letter outlines specific violations of

KratomNC – Warning Letter

On May 16, 2019, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to KratomNC, highlighting significant concerns regarding the marketing and safety of

Kratom Spot – Warning Letter

On May 18, 2018, the U.S. Food and Drug Administration (FDA) issued a warning letter to Kratom Spot, a retailer of kratom products, addressing significant regulatory

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