# FDA 483 - Aventura Fertility & IVF - March 10, 2022

Source: https://www.globalkeysolutions.net/records/483/aventura-fertility-ivf/6f5c5956-8e2c-4096-9863-14e4fdd90043

> FDA 483 for Aventura Fertility & IVF on March 10, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aventura Fertility & IVF
- Inspection Date: 2022-03-10
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Aventura Fertility & IVF in Aventura, FL, identified significant issues with donor eligibility determination and screening for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to properly document reasons for donor ineligibility, adequately screen donors for communicable disease risks, and establish compliant procedures for donor eligibility. These deficiencies indicate a lack of robust controls over critical aspects of donor screening and record-keeping.

## Related Officers

- [Ivan E. Reyes](https://www.globalkeysolutions.net/people/ivan-e-reyes/69bac3eb-f63c-45f0-8420-85a7e06b884a)

Company: https://www.globalkeysolutions.net/companies/aventura-fertility-ivf/3e0c7b54-6076-4dae-82c5-15e2d1ab372a

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6