# FDA 483 - iuvo BioScience Operations, LLC - May 15, 2026

Source: https://www.keypedia.com/records/483/iuvo-bioscience-operations-llc/8e7f2e3f-fe83-4e5e-a41d-ed9ac2e12d8a

> FDA 483 for iuvo BioScience Operations, LLC on May 15, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: iuvo BioScience Operations, LLC
- Inspection Date: 2026-05-15
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Canyon Rush, LLC, a contract laboratory in Rush, NY, was cited for significant deficiencies in laboratory controls and record-keeping during an FDA inspection. Observations included a pervasive lack of contemporaneous documentation and data integrity issues, failures to follow internal investigation procedures, and inadequate incubation conditions for microbiological testing. These issues indicate a systemic breakdown in quality control and data reliability.

## Related Documents

- [483 - 2021-05-27](https://www.keypedia.com/records/483/iuvo-bioscience-operations-llc/340d6f6f-5f9c-4bca-a6b1-4c7879fda1b2)
- [EIR - 2022-04-15](https://www.keypedia.com/records/eir/iuvo-bioscience-operations-llc/f9d1fb36-ea4a-40d1-88e2-a49ad48cfc4c)

## Related Officers

- [Lauren H. Augustyniak](https://www.keypedia.com/people/lauren-h-augustyniak/bde81fac-921f-494b-969b-38770fceda7e)

Company: https://www.keypedia.com/companies/iuvo-bioscience-operations-llc/0d802369-f7b4-423e-8a7c-7a9e2dae4896

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961