# FDA 483 - Michigan Reproductive and IVF Center, PLLC - April 27, 2023

Source: https://www.keypedia.com/records/483/michigan-reproductive-and-ivf-center-pllc/62fd22e5-f19f-4500-981c-fd27ac336e2d

> FDA 483 for Michigan Reproductive and IVF Center, PLLC on April 27, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Michigan Reproductive and IVF Center, PLLC
- Inspection Date: 2023-04-27
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Michigan Reproductive and IVF Center, PLLC in Grand Rapids, MI, revealed significant deficiencies in donor screening practices for reproductive human tissue. The firm failed to adequately screen oocyte and semen donors for communicable disease agents, specifically by omitting physical examinations of the pelvic and reproductive organ areas. Additionally, the firm deemed a donor eligible despite an incomplete screening history and a reactive Hepatitis B test, indicating a failure to properly assess donor eligibility.

## Related Officers

- [Erma Zaimova](https://www.keypedia.com/people/erma-zaimova/87da23ad-48bb-4096-9d8a-e8511c6b5c98)

Company: https://www.keypedia.com/companies/michigan-reproductive-and-ivf-center-pllc/88117601-3247-4324-9232-c339db8e9365

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0