FDA WARNING_LETTER - R-Garden LLC - August 15, 2019

The FDA conducted an inspection of R-Garden's facility from August 5-15, 2019, identifying serious violations of dietary supplement CGMP regulations (21 CFR Part 111), causing products to be adulterated. Additionally, product labels and promotional materials (website, catalog, newsletters) for products like Vitamin O, Gamma-Zyme, and Protease Plus contain claims establishing them as unapproved new drugs under 21 U.S.C. § 321(g)(1)(B) due to intended use in disease cure, mitigation, treatment, or prevention. These products are also considered "new drugs" under 21 U.S.C. § 321(p) and misbranded under 21 U.S.C. § 352(f)(1) for lacking adequate directions for use.

CGMP violations include failure to establish and follow written procedures for quality control operations (21 CFR 111.103) and lack of specifications for dietary supplement labels (21 CFR 111.70(d)). The company's responses to the FDA 483 were deemed inadequate as they did not provide their own firm's quality control procedures or label specifications.

Furthermore, several products are misbranded under 21 U.S.C. § 343 due to incorrect nutrition information presentation (e.g