FDA 483 - Nutrix International LLC - April 25, 2025

Nutrix International LLC, an OTC drug manufacturer in Salt Lake City, UT, was cited for numerous significant deficiencies during an FDA inspection. Key issues include a failure to thoroughly investigate out-of-specification water system results, lack of validation for their water system, inadequate raw material testing for harmful contaminants, and insufficient finished product testing. The firm also failed to maintain proper batch records and adequate facility conditions, indicating systemic quality control and manufacturing process control failures.