FDA WARNING_LETTER - Homeodynamics, LLC - August 25, 2017

An FDA inspection of Homeodynamics, LLC, in Madison, Wisconsin, concluded on August 25, 2017, revealing significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111) and misbranding issues. The firm's dietary supplements are deemed adulterated due to CGMP non-compliance. Additionally, several products, including "Zika Virosinum" and "Carcinoma Mammae," are considered unapproved new drugs because their claims establish intent for disease treatment, making them misbranded under 21 U.S.C. § 352(f)(1) for lacking adequate directions for use. The introduction of these misbranded drugs violates 21 U.S.C. § 331(a).

CGMP violations include failure to collect and hold reserve samples (21 CFR 111.83(a)), establish written procedures for packaging and labeling (21 CFR 111.403), establish procedures for equipment maintenance, cleaning, and calibration (21 CFR 111.25(a) and (c)), and establish personnel qualification procedures (21 CFR 111.8). The firm's responses regarding these CGMP issues were deemed insufficient or incomplete.

Furthermore, several dietary supplement products are misbranded under 21 U.S.C. § 343 and 21 CFR Part 101 for failing to declare common or usual ingredient names (21 CFR 101.4), having incorrect or incomplete serving sizes (21 CFR 101.9(b)(7)), improper presentation of nutrition information (21 CFR 101.36), and failing to include quantitative amounts of dietary ingredients by weight (21 CFR 101.36). The FDA also provided additional labeling comments. Homeodynamics must promptly correct all violations within 15 working days, providing documentation of corrective actions to avoid legal action, including seizure, injunction, and reinspection fees.