# FDA 483 - Women & Infants Hospital Of Rhode Island  Women & Infants' Fertility Center - August 10, 2021

Source: https://www.globalkeysolutions.net/records/483/women-infants-hospital-of-rhode-island-women-infants-fertility-center/659b614d-adbc-4324-b51a-cf885da3f8c5

> FDA 483 for Women & Infants Hospital Of Rhode Island  Women & Infants' Fertility Center on August 10, 2021. 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: 2021-08-10
- Product Type: biologics
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: The FDA issued a Form 483 to Women & Infants Hospital Of Rhode Island Women & Infants' Fertility Center in Providence, RI, following an inspection of their human tissue (reproductive) establishment. The inspection revealed deficiencies in donor screening for communicable disease risk factors and in the timely collection of donor specimens for testing. These observations indicate potential non-compliance with regulations concerning donor eligibility and product safety.

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## 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