# FDA 483 - Rejuvenating Fertility Center PLLC - October 25, 2024

Source: https://www.keypedia.com/records/483/rejuvenating-fertility-center-pllc/5ca5084c-0620-4637-8211-a004145e7bd0

> FDA 483 for Rejuvenating Fertility Center PLLC on October 25, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rejuvenating Fertility Center PLLC
- Inspection Date: 2024-10-25
- Product Type: biologics
- Office Name: New England District Office
- Summary: An FDA inspection of Rejuvenating Fertility Center PLLC in Westport, CT, revealed significant deficiencies in their human reproductive tissue operations. The firm failed to establish adequate procedures for HCT/P donor screening and did not collect donor specimens for communicable disease testing at appropriate times. Additionally, donor eligibility determinations were made despite testing being performed outside required timeframes.

## Related Officers

- [Investigator](https://www.keypedia.com/people/anthony-n-onianwa/910dd164-8542-4259-b11f-ea3a3f6d7baa)

Company: https://www.keypedia.com/companies/rejuvenating-fertility-center-pllc/1568f407-f2d8-41db-be89-9b4620d5eeb2

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144