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InnoMark, Inc. was cited for manufacturing adulterated dietary supplements in violation of Current Good Manufacturing Practice (cGMP) regulations under 21 CFR Part 111. Inspectors found that the company failed to establish required product specifications for the strength and composition of finished dietary supplements, specifically identifying deficiencies in the finished product specification sheet for one of their dietary supplement products. The violations were significant enough that the FDA determined the affected dietary supplements were adulterated and unsuitable for distribution under federal law.