# FDA WARNING_LETTER - Innovita, LLC - March 06, 2017

Source: https://www.keypedia.com/records/warning_letter/innovita-llc/9ee248ce-6dba-4700-993d-6d5ac16610dc

> FDA WARNING_LETTER for Innovita, LLC on March 06, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Innovita, LLC
- Inspection Date: 2017-03-06
- Product Type: Drugs
- Office Name: Denver District Office
- Summary: 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)),

## Related Officers

- [District Director](https://www.keypedia.com/people/latonya-mitchell/433fa355-5a9b-4723-876c-782d1ca5737d)
- [ Compliance Officer](https://www.keypedia.com/people/nancy-g-schmidt/b4b78b27-1ca2-4aba-8eb5-f31e50c3e7b9)

Company: https://www.keypedia.com/companies/innovita-llc/fa939ae4-b677-4d07-aa04-b23511f1b4ba

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face