FDA Inspection
Upstate New York Transplant Services IncUpstate New York Transplant Services Inc – FDA Inspection, Aug 9, 2010
Record Details
This FDA Inspection record concerns Upstate New York Transplant Services Inc, with an inspection on August 9, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 9, 2010
- Product Type
- Biologics
View Company Profile
ID · 0ea283fe-5e01-4757-86ff-d77292725e2b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 675431
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 606.100(b)(14)QC procedures for supplies and reagents
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Upstate New York Transplant Services Inc
7| Date | Classification | Office | Project area |
|---|---|---|---|
| October 10, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 19, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 29, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 11, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 19, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Upstate New York Transplant Services Inc
- FDA Inspection 1221533 - 2023-10-10
- FDA Inspection 1111824 - 2019-11-19
- FDA Inspection 1034170 - 2017-11-29
- FDA Inspection 965818 - 2016-04-11
- FDA Inspection 880533 - 2014-05-19
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