# FDA 483 - Steiner Biotechnology LLC - June 28, 2019

Source: https://www.keypedia.com/records/483/steiner-biotechnology-llc/51468c89-6896-40e8-bc3d-3f66e34fc0f6

> FDA 483 for Steiner Biotechnology LLC on June 28, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steiner Biotechnology LLC
- Inspection Date: 2019-06-28
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Steiner Biotechnology, LLC in Henderson, NV, a nonclinical laboratory, revealed significant deficiencies in their Good Laboratory Practice (GLP) compliance. Observations included multiple deviations from study protocols, use of unqualified personnel for surgical procedures, and a complete lack of quality assurance unit oversight for ongoing studies. The firm also failed to maintain adequate records, provide proper animal housing, and ensure proper specimen identification and data archival.

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## Related Officers

- [Investigator ](https://www.keypedia.com/people/dustin-tran/52b41643-a5f9-4b2e-8da4-24beca42b1cd)

Company: https://www.keypedia.com/companies/steiner-biotechnology-llc/cbc387b4-9634-400a-a041-f876624ba732

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b