Loading…
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.