# FDA 483 - Women & Infants Hospital Of Rhode Island  Women & Infants' Fertility Center - January 27, 2020

Source: https://www.globalkeysolutions.net/records/483/women-infants-hospital-of-rhode-island-women-infants-fertility-center/418facbf-9028-4e9f-9d1a-9fc7bb1fbcb7

> FDA 483 for Women & Infants Hospital Of Rhode Island  Women & Infants' Fertility Center on January 27, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Women & Infants Hospital Of Rhode Island  Women & Infants' Fertility Center
- Inspection Date: 2020-01-27
- Product Type: biologics
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Women & Infants Hospital Of Rhode Island, a human reproductive establishment, received a Form 483 citing two observations related to donor screening. The facility failed to adequately screen an oocyte donor for Zika virus risk factors due to an incomplete medical history form. Additionally, the firm lacked established written procedures for HCT/P donor screening, specifically for medical health history interviews.

## Related Documents

- [483 - 2021-08-10](https://www.globalkeysolutions.net/records/483/women-infants-hospital-of-rhode-island-women-infants-fertility-center/659b614d-adbc-4324-b51a-cf885da3f8c5)

## Related Officers

- [Lorayne A McGuinness](https://www.globalkeysolutions.net/people/lorayne-a-mcguinness/537b1a24-c006-49d9-9d24-5701c7124f9c)

Company: https://www.globalkeysolutions.net/companies/women-infants-hospital-of-rhode-island-women-infants-fertility-center/f81d9771-92b1-434c-9155-bf5c8ef4f1b8

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7