FDA WARNING_LETTER - davis ventures, inc - March 18, 2020

The FDA inspected the facility at 4565 Kipling St., Wheatridge, Colorado, from March 3-18, 2020, revealing serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111). These violations render the dietary supplement products adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).

Specifically, the firm failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Despite receiving packaged and labeled finished dietary supplements, no written procedures were provided to ensure proper storage conditions (temperature, humidity, light) to maintain product identity, purity, strength, and composition (21 CFR 111.455(a)). Responses dated March 27 and May 27, 2020, were deemed insufficient as they described current practices but lacked the required written procedures.

Additionally, several dietary supplement products (Fos-Idophilus, Breathe Eze, D-Stress, Herbal N-Zyme, System Fresh, Ur-NAry Fresh) were found to be misbranded under section 403 of the Act due to non-compliance with labeling requirements (21 CFR 101). Specific misbranding issues included: * Incorrect serving size declaration (System Fresh). * Failure