Nature’s Fusions LLC

Warning LetterOpen

Ms. Lori A. Peterson Chief Information Officer Quality Assurance/Owner Nature’s Fusions LLC 57 North 1380 West Orem , UT 84057 United StatesFEI 3012853845Issued Jun 25, 2025Center for Drug Evaluation and Research (CDER)

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Violations5

Issue DateJun 25, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Nature’s Fusions LLC
Location: Ms. Lori A. Peterson Chief Information Officer Quality Assurance/Owner Nature’s Fusions LLC 57 North 1380 West Orem , UT 84057 United States
FEI Number: 3012853845
Country: United States
Issue Date: June 25, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Nature's Fusions LLC, a drug manufacturer in Orem, Utah, failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, particularly regarding over-the-counter products like hand sanitizers. The FDA identified critical violations including the absence of a written stability testing program to assess product characteristics and determine appropriate expiration dates, inadequate facility space controls to prevent mix-ups and contamination, and use of expired bulk materials that were repackaged with assigned expiration dates without any supporting stability studies. The company had not responded to the FDA's initial inspection findings documented on Form FDA 483 at the time the warning letter was issued in June 2025.

Nature’s Fusions LLC FDA Warning Letter, June 25, 2025