LXR Biotech, LLC

Warning LetterOpen

Mr. Anthony G. Orzechowski Vice President and Chief Operating Officer LXR Biotech, LLC 2983 Waterview Dr. Rochester Hills , MI 48309-4600 United States Tonyo@lxrbiotech.comFEI 3010744574Issued Dec 23, 2025Human Foods Program

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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 3010744574.

Violations4

Issue DateDec 23, 2025

Product TypeDietary Supplements

StatusOpen

Letter Details

Firm: LXR Biotech, LLC
Location: Mr. Anthony G. Orzechowski Vice President and Chief Operating Officer LXR Biotech, LLC 2983 Waterview Dr. Rochester Hills , MI 48309-4600 United States Tonyo@lxrbiotech.com
FEI Number: 3010744574
Country: United States
Issue Date: December 23, 2025
Issuing Office: Human Foods Program
Product Type: Dietary Supplements
Status: Open

Summary

LXR Biotech, LLC received a warning for manufacturing adulterated dietary supplements (Eternal Energy Grape and Eternal Energy Tropical Punch) that violated Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 111. The company failed to establish proper product specifications for identity, purity, strength, and composition of finished batches, specifically omitting key ingredients from their finished product specifications document despite using them in manufacturing. An FDA inspection conducted February 25 through March 12, 2025 identified these significant violations, and the company's subsequent responses dated April, May, and June 2025 were found inadequate to address the deficiencies.

LXR Biotech, LLC FDA Warning Letter, December 23, 2025