# FDA 483 - Nutrix International LLC - April 25, 2025

Source: https://www.keypedia.com/records/483/nutrix-international-llc/ef34f484-37e2-4859-a85a-e8d50e7e7cb4

> FDA 483 for Nutrix International LLC on April 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nutrix International LLC
- Inspection Date: 2025-04-25
- Product Type: drugs
- Office Name: Denver District Office
- Summary: 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.

## Related Documents

- [483 - 2019-04-11](https://www.keypedia.com/records/483/nutrix-international-llc/14758906-0be3-48a6-89e1-c07341b201d6)

## Related Officers

- [Director of Compliance Branch](https://www.keypedia.com/people/ronda-r-lloyd-jones/1446ba41-f1f2-4d40-8902-021b2bef3a53)
- [Michael Z. Weigman](https://www.keypedia.com/people/michael-z-weigman/fcf79bb1-87cc-476c-a1af-758ef0126ee9)

Company: https://www.keypedia.com/companies/nutrix-international-llc/d406360d-eaa1-4aab-a17f-a59670980308

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face