# FDA 483 - Boston IVF at The Women's Hospital - September 09, 2025

Source: https://www.keypedia.com/records/483/boston-ivf-at-the-womens-hospital/224cf30e-d14b-40d3-970d-4f8551f4a257

> FDA 483 for Boston IVF at The Women's Hospital on September 09, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boston IVF at The Women's Hospital
- Inspection Date: 2025-09-09
- Product Type: biologics
- Office Name: Detroit District Office
- Summary: Boston IVF Fertility Services at The Women's Hospital, LLC, an HCT/P Reproductive Firm in Newburgh, IN, was cited for two significant observations during an FDA inspection. The firm failed to adequately screen donors for communicable disease agents, specifically Creutzfeldt-Jakob Disease, due to a deficient questionnaire. Additionally, the firm lacked established and maintained procedures for HCT/P donor screening, which did not address critical aspects like identifying relevant communicable diseases or necessary follow-up inquiries.

## Related Documents

- [483 - 2025-09-09](https://www.keypedia.com/records/483/boston-ivf-at-the-womens-hospital/ca2d7a37-22a6-44fd-b88a-9fa20307fc61)

## Related Officers

- [Lesley Mae P. Lutao](https://www.keypedia.com/people/lesley-mae-p-lutao/bfdcc755-28e5-4caf-91f9-b9579df4731e)

Company: https://www.keypedia.com/companies/boston-ivf-at-the-womens-hospital/b233d5d2-5819-4a94-bf11-ef47dd9f4d81

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03