FDA Inspection
VA Boston Healthcare SystemVA Boston Healthcare System – FDA Inspection, Aug 8, 2014
Record Details
This FDA Inspection record concerns VA Boston Healthcare System, with an inspection on August 8, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- VA Boston Healthcare System
- Inspection Date
- August 8, 2014
- Product Type
- Biologics
View Company Profile
ID · 2ed019af-abb1-456e-adbb-0394c758be30
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 892551
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.160(a)(2)Determination of lot numbers and supplies
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of VA Boston Healthcare System
7| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2025 | VAI | New England District Office | Blood and Blood Products |
| 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 |
| March 15, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for VA Boston Healthcare System
- FDA Inspection 1277921 - 2025-08-08
- FDA Inspection 1190571 - 2022-11-01
- FDA Inspection 1079193 - 2019-01-18
- FDA Inspection 996162 - 2016-12-23
- FDA Inspection 772496 - 2012-03-15
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