Russell M. Moody
CEO/Owner
InnoMark, Inc.
4041 S. River Rd
Saint George , UT 84790
United StatesFEI 3005114318Issued Sep 1, 2023Division of Human and Animal Food Operations West IV
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3005114318.
Violations18
Issue DateSep 1, 2023
Product TypeDietary Supplements
StatusOpen
Letter Details
Firm
InnoMark, Inc.
Location
Russell M. Moody
CEO/Owner
InnoMark, Inc.
4041 S. River Rd
Saint George , UT 84790
United States
FEI Number
3005114318
Country
United States
Issue Date
September 01, 2023
Issuing Office
Division of Human and Animal Food Operations West IV
Product Type
Dietary Supplements
Status
Open
Summary
InnoMark, Inc. was cited for manufacturing adulterated dietary supplements in violation of Current Good Manufacturing Practice (cGMP) regulations under 21 CFR Part 111. Inspectors found that the company failed to establish required product specifications for the strength and composition of finished dietary supplements, specifically identifying deficiencies in the finished product specification sheet for one of their dietary supplement products. The violations were significant enough that the FDA determined the affected dietary supplements were adulterated and unsuitable for distribution under federal law.
InnoMark, Inc. FDA Warning Letter, September 1, 2023