FDA Inspection
American Red Cross Blood Services - Massachusetts RegionAmerican Red Cross Blood Services - Massachusetts Region – FDA Inspection, Jun 4, 2015
Record Details
This FDA Inspection record concerns American Red Cross Blood Services - Massachusetts Region, with an inspection on June 4, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 4, 2015
- Product Type
- Biologics
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ID · 3405ea75-5f36-4680-af98-d8258edba9d4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 934401
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.160(b)Required records
- 21 CFR 211.67(b)(1)Cleaning SOP/responsibility
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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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 |
| May 24, 2017 | 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 1017552 - 2017-05-24
- FDA Inspection 850683 - 2013-09-24
- FDA Inspection 775512 - 2012-03-26
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