# FDA 483 - ALLcare Fertility Center - November 06, 2024

Source: https://www.keypedia.com/records/483/allcare-fertility-center/13e19996-ff2e-4f30-b543-d8974fcfccd0

> FDA 483 for ALLcare Fertility Center on November 06, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ALLcare Fertility Center
- Inspection Date: 2024-11-06
- Product Type: biologics
- Office Name: New York District Office
- Summary: ALLCARE Fertility Center in New York, NY, was cited for multiple deficiencies related to donor eligibility determination and screening for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The inspection revealed failures in documenting donor eligibility, collecting specimens at appropriate times for communicable disease testing, and maintaining adequate procedures for donor screening. Additionally, the firm failed to properly label HCT/Ps not requiring donor eligibility determination and maintained 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/allcare-fertility-center/cbb75cd5-3bf6-4df0-9afe-9c45ab63c0d7

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