# FDA 483 - Rhode Island Blood Center, a Division of New York Blood Center, Inc., Westerly Donor Center - April 15, 2022

Source: https://www.keypedia.com/records/483/rhode-island-blood-center-a-division-of-new-york-blood-center-inc-westerly-donor-center/3f787d5e-455d-4355-9b13-7d2546b81b9a

> FDA 483 for Rhode Island Blood Center, a Division of New York Blood Center, Inc., Westerly Donor Center on April 15, 2022. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Rhode Island Blood Center, a Division of New York Blood Center, Inc., Westerly Donor Center
- Inspection Date: 2022-04-15
- Product Type: biologics
- Office Name: Division of Northeast Imports 
- Summary: The FDA inspected the Rhode Island Blood Center, Westerly Donor Center, and issued a Form 483 with two observations. The inspection revealed failures in determining donor health, specifically regarding the assessment of phlebotomy sites for inflammation and the examination for signs of injected drug use. These issues indicate deficiencies in donor screening procedures.

## Related Officers

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

Company: https://www.keypedia.com/companies/rhode-island-blood-center-a-division-of-new-york-blood-center-inc-westerly-donor-center/eb7be4e4-3bcf-4d2e-aa3c-c8de08b75a1a

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94