FDA WARNING_LETTER - Innovita, LLC - March 06, 2017

The FDA inspected Irmo-Vita, LLC from February to March 2017, identifying significant violations of dietary supplement cGMP regulations (21 CFR Part 111), causing products to be adulterated under 21 U.S.C. § 342(g)(1).

Additionally, a review of the company's website and product labeling in August 2017 revealed that products like Phung-Ex, Micro-Site, Kardi-Air, Pro-Prosta, Xpleen, Immunis, Hysta-Min, and Bacto-Ex are unapproved new drugs under 21 U.S.C. § 321(p) due to disease treatment claims, violating 21 U.S.C. §§ 331(d) and 355(a). Kardi-Air is also misbranded under 21 U.S.C. § 352(f)(1) for lacking adequate directions for use.

Key cGMP violations include: 1. Failure to establish adequate identity specifications for dietary ingredient components (21 CFR 111.70(b)(1)), relying on insufficient organoleptic analysis for powdered/liquid botanicals. 2. Failure to establish complete finished product specifications for identity, purity, strength, and composition (21 CFR 111.70(e)),