FDA Inspection
Rhode Island Blood Center, a Division of New York Blood Center, Inc. Warwick Donor CenterRhode Island Blood Center, a Division of New York Blood Center, Inc. Warwick Donor Center – FDA Inspection, May 3, 2018
Record Details
This FDA Inspection record concerns Rhode Island Blood Center, a Division of New York Blood Center, Inc. Warwick Donor Center, with an inspection on May 3, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 3, 2018
- Product Type
- Biologics
- Person
- Lorayne A. Mcguinness
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ID · 5e75d0ca-0c38-4ab0-b4d5-f9bc10f05ea7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1050503
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 606.100(b)(5)Accurate measurement of quantity of blood
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Rhode Island Blood Center, a Division of New York Blood Center, Inc. Warwick Donor Center
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 5, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 5, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 16, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 5, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 23, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Rhode Island Blood Center, a Division of New York Blood Center, Inc. Warwick Donor Center
- FDA Inspection 1229751 - 2024-01-05
- FDA Inspection 1112443 - 2019-12-05
- FDA Inspection 970547 - 2016-05-16
- FDA Inspection 854113 - 2013-11-05
- FDA Inspection 783099 - 2012-05-23
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