FDA WARNING_LETTER - Heron Botanicals, Inc. - September 17, 2014

The FDA conducted an inspection of Dr. Yarnell's dietary supplement manufacturing facility in Kingston, Washington, from September 2-17, 2014, identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). These violations render the manufactured dietary supplements adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, product labeling was found to be misbranded under section 403 of the Act.

Key violations include: 1. Failure to establish finished product specifications for identity, purity, strength, and composition (21 CFR 111.70(e)), specifically for Echinacea angustifolia and Dipsacus sylvestris products. 2. Failure to establish component specifications to ensure finished product specifications are met (21 CFR 111.70(b)(2)), as raw material testing was inadequate for purity, strength, and composition. 3. Failure to establish in-process specifications for identity, purity, strength, and composition during manufacturing, particularly for maceration of Echinacea angustifolia and Dipsacus sylvestris (21 CFR 111.70(c)(1)). 4. Failure to reject components that did not meet identity specifications (21 CFR 111.77(b)), with instances of Dipsacus