FDA Inspection
VA New York Harbor Healthcare SystemVA New York Harbor Healthcare System – FDA Inspection, May 12, 2015
Record Details
This FDA Inspection record concerns VA New York Harbor Healthcare System, with an inspection on May 12, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 12, 2015
- Product Type
- Biologics
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ID · 04e529af-cd12-4c95-a5b6-4fc928ae395b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 925908
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.100(b)(16)Labeling procedures to avoid labeling mix-ups
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Other FDA inspections of VA New York Harbor Healthcare System
7| Date | Classification | Office | Project area |
|---|---|---|---|
| January 29, 2025 | VAI | New York District Office | Blood and Blood Products |
| August 9, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| November 8, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 13, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 6, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for VA New York Harbor Healthcare System
- FDA Inspection 1259489 - 2025-01-29
- FDA Inspection 1177322 - 2022-08-09
- FDA Inspection 1074512 - 2018-11-08
- FDA Inspection 994484 - 2016-12-13
- FDA Inspection 834541 - 2013-06-06
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