# FDA 483 - Manhattan Fertility Services LLC - November 05, 2024

Source: https://www.globalkeysolutions.net/records/483/manhattan-fertility-services-llc/2afc305c-89b9-4d19-93e1-8dba4189735c

> FDA 483 for Manhattan Fertility Services LLC on November 05, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Manhattan Fertility Services LLC
- Inspection Date: 2024-11-05
- Product Type: biologics
- Office Name: New York District Office
- Summary: Manhattan Fertility Services LLC in New York was cited for significant deficiencies related to donor screening, eligibility determination, and labeling of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The inspection revealed inadequate procedures for donor screening, failure to determine donor eligibility based on complete screening and testing, and improper labeling of HCT/Ps from ineligible donors. Additionally, donor eligibility records were found to be inaccurate and incomplete.

## Related Documents

- [483 - 2023-04-06](https://www.globalkeysolutions.net/records/483/manhattan-fertility-services-llc/fb96e8e6-f20a-44a8-8a3c-e086b5692cc5)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/manhattan-fertility-services-llc/ed1c1165-d7fe-42fe-8f99-d755b4474938

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d