# FDA 483 - IVFMD - Advanced Reproductive Laboratory - June 04, 2019

Source: https://www.keypedia.com/records/483/ivfmd-advanced-reproductive-laboratory/0928eed7-29bd-4070-a896-837b928763c6

> FDA 483 for IVFMD - Advanced Reproductive Laboratory on June 04, 2019. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: IVFMD - Advanced Reproductive Laboratory
- Inspection Date: 2019-06-04
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: IVFMD - Advanced Reproductive Laboratory in Irving, TX, was inspected for human reproductive tissue practices and received a Form 483 with three observations. The firm failed to adequately screen oocyte donors for Zika virus and transferred tissues without counseling recipients. Additionally, the facility did not adhere to its own SOP for handling CMV IgG positive semen, transferring it to CMV negative or unknown status recipients without counseling. Finally, donor identifying information was included in records accompanying HCT/Ps.

## Related Officers

- [Elmina E Akwo](https://www.keypedia.com/people/elmina-e-akwo/ecd9066d-1647-4765-ad86-dbe5280241c5)

Company: https://www.keypedia.com/companies/ivfmd-advanced-reproductive-laboratory/d718f7e9-337b-4e05-9d8a-75a78206ab81

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9