# FDA 483 - Steinleitner, Alex, MD, Inc - June 26, 2025

Source: https://www.keypedia.com/records/483/steinleitner-alex-md-inc/13ffb40d-cfb3-4eca-afe3-a2d03532c6b4

> FDA 483 for Steinleitner, Alex, MD, Inc on June 26, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steinleitner, Alex, MD, Inc
- Inspection Date: 2025-06-26
- Product Type: biologics
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Steinleitner, Alex, MD, Inc. in San Luis Obispo, CA, a reproductive medicine establishment, revealed significant deficiencies in donor screening and eligibility determination processes. The firm failed to adequately screen oocyte and semen donors for communicable disease risk factors and lacked proper procedures for donor eligibility. Additionally, donor eligibility records were incomplete, missing critical establishment address information.

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Company: https://www.keypedia.com/companies/steinleitner-alex-md-inc/c878f9c5-9bcb-49b1-a678-642078196f2b

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b