# FDA 483 - Steiner Biotechnology LLC - February 14, 2025

Source: https://www.keypedia.com/records/483/steiner-biotechnology-llc/c121211f-2f11-438f-ac7a-2541c2e0c8be

> FDA 483 for Steiner Biotechnology LLC on February 14, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steiner Biotechnology LLC
- Inspection Date: 2025-02-14
- Product Type: device
- Office Name: San Francisco District Office
- Summary: Steiner Biotechnology LLC, a medical device manufacturer in Henderson, NV, received a Form 483 with twelve observations highlighting severe and systemic deficiencies in its quality management system. The inspection revealed a pervasive lack of established and adequately documented procedures across critical areas, including design control, process validation, risk analysis, quality audits, environmental control, CAPA, management review, device master records, purchasing controls, equipment qualification, device history records, and acceptance activities. Many of these issues are repeat observations from previous inspections, indicating persistent non-compliance with regulatory requirements.

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## Related Officers

- [investigator](https://www.keypedia.com/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)

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

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df