FDA Inspection
VA Boston Healthcare SystemVA Boston Healthcare System – FDA Inspection, Aug 8, 2025
Record Details
This FDA Inspection record concerns VA Boston Healthcare System, with an inspection on August 8, 2025, issued by the New England District Office, covering biologics.
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ID · 2b8e355c-86c7-4b8c-81fc-df1d1541fa26
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1277921
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.100(c)Thorough investigations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of VA Boston Healthcare System
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 1, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 18, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 23, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 8, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 15, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for VA Boston Healthcare System
- FDA Inspection 1190571 - 2022-11-01
- FDA Inspection 1079193 - 2019-01-18
- FDA Inspection 996162 - 2016-12-23
- FDA Inspection 892551 - 2014-08-08
- FDA Inspection 772496 - 2012-03-15
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