FDA Inspection
Yale-New Haven Hospital - York Street CampusYale-New Haven Hospital - York Street Campus – FDA Inspection, Mar 16, 2012
Record Details
This FDA Inspection record concerns Yale-New Haven Hospital - York Street Campus, with an inspection on March 16, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 16, 2012
- Product Type
- Biologics
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ID · 517e05b8-f08d-4ff8-a575-e1a26c2b47db
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 772476
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 211.194(b)Test method modification records do not include
- 21 CFR 606.100(b)(14)QC procedures for supplies and reagents
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Other FDA inspections of Yale-New Haven Hospital - York Street Campus
10| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 22, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 23, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 17, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 21, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Yale-New Haven Hospital - York Street Campus
- FDA Inspection 1281051 - 2025-08-22
- FDA Inspection 1235112 - 2024-03-22
- FDA Inspection 1173197 - 2022-06-23
- FDA Inspection 1064705 - 2018-08-17
- FDA Inspection 966865 - 2016-04-21
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