On September 1, 2023, the FDA issued a Warning Letter to InnoMark, Inc. following an inspection of the company’s manufacturing facility, which found its dietary supplements to be adulterated because they were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices (CGMP). The products were described as “stick dietary supplements,” but specific products or ingredients were not named in the letter.

Violations noted by the FDA included failure to establish product specifications for strength and composition of the finished batch of a dietary supplement, failure to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, and failure to ensure that manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement.

Additionally, some of the company’s products were found to be misbranded because the labels failed to include serving sizes, failed to bear a domestic address or phone number to report a serious adverse event, were false and misleading, or failed to declare all common or usual names of each ingredient.

The company must respond to the FDA in writing within 15 days of receipt of the warning explaining the specific steps taken to address the violations.

For more information, use the link below.

Warning: InnoMark, Inc.

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