FDA Inspection
Rhode Island Blood Center, A Division of New York Blood Center, Inc.Rhode Island Blood Center, A Division of New York Blood Center, Inc. – FDA Inspection, Jun 21, 2012
Record Details
This FDA Inspection record concerns Rhode Island Blood Center, A Division of New York Blood Center, Inc., with an inspection on June 21, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 21, 2012
- Product Type
- Biologics
View Company Profile
ID · a122c074-3ded-41ca-9950-fdf193021aaa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 788124
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
9- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 600.10(b)Personnel capabilities
- 21 CFR 610.41Donor Deferral
- 21 CFR 606.160(b)Required records
- 21 CFR 606.65Safe, sanitary, orderly storage
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Rhode Island Blood Center, A Division of New York Blood Center, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2025 | NAI | New England District Office | Human Cellular, Tissue, and Gene Therapies |
| March 7, 2023 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| July 26, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 14, 2017 | Not classified | New England District Office | |
| November 7, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Rhode Island Blood Center, A Division of New York Blood Center, Inc.
- FDA Inspection 1277157 - 2025-08-01
- FDA Inspection 1201246 - 2023-03-07
- FDA Inspection 1106753 - 2019-07-26
- FDA Inspection 1025554 - 2017-09-14
- FDA Inspection 995774 - 2016-11-07
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