FDA Inspection
American Red Cross Blood Services - Massachusetts RegionAmerican Red Cross Blood Services - Massachusetts Region – FDA Inspection, May 24, 2017
Record Details
This FDA Inspection record concerns American Red Cross Blood Services - Massachusetts Region, with an inspection on May 24, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 24, 2017
- Product Type
- Biologics
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ID · 0fb77e4b-257b-4330-9f95-805ecc168f28
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017552
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 606.170(a)Adverse Reaction - Investigations
- 21 CFR 606.160(b)Required records
- 21 CFR 211.192Extent of discrepancy, failure investigations
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Other FDA inspections of American Red Cross Blood Services - Massachusetts Region
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2024 | Not classified | New England District Office | |
| August 28, 2020 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 4, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 24, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 26, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for American Red Cross Blood Services - Massachusetts Region
- FDA Inspection 1249546 - 2024-09-13
- FDA Inspection 1130057 - 2020-08-28
- FDA Inspection 934401 - 2015-06-04
- FDA Inspection 850683 - 2013-09-24
- FDA Inspection 775512 - 2012-03-26
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