# FDA 483 - Aligneage Fertility Laboratory, LLC - October 21, 2025

Source: https://www.keypedia.com/records/483/aligneage-fertility-laboratory-llc/d52d1926-b569-4aa3-8fe8-030b17dfc054

> FDA 483 for Aligneage Fertility Laboratory, LLC on October 21, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aligneage Fertility Laboratory, LLC
- Inspection Date: 2025-10-21
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Aligneage Fertility Laboratory, LLC in New York, NY, was inspected regarding its reproductive human tissue operations. The inspection revealed significant deficiencies in establishing and maintaining procedures for screening HCT/P donors, particularly directed semen donors. Issues included inadequate screening for communicable disease risk factors and inaccurate donor eligibility records.

## Related Officers

- [Investigator](https://www.keypedia.com/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.keypedia.com/companies/aligneage-fertility-laboratory-llc/97141387-b3d8-43b4-a52f-c44565dcb41b

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