FDA Inspection
University of Rochester - Strong Memorial HospitalUniversity of Rochester - Strong Memorial Hospital – FDA Inspection, Jul 24, 2026
Record Details
This FDA Inspection record concerns University of Rochester - Strong Memorial Hospital, with an inspection on July 24, 2026, issued by the New York District Office, covering biologics.
- Inspection Date
- July 24, 2026
- Product Type
- Biologics
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ID · ba1a74c4-3c1b-49c3-b3b5-1c822e8525eb
Inspection Facts
- Inspection number
- 1327728
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 606.100(a)SOP compliance
- 21 CFR 630.10(g)(2)(i)Donor's Acknowledgment Procedures
- 21 CFR 630.10(g)(2)(ii)Donor's Acknowledgment - Exculpatory language
- 21 CFR 630.40(b)(2)Type of donations
- 21 CFR 640.120(a)Notification to and approval from CBER
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Other FDA inspections of University of Rochester - Strong Memorial Hospital
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 11, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 6, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 3, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 5, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for University of Rochester - Strong Memorial Hospital
- FDA Inspection 1218862 - 2023-09-13
- FDA Inspection 1039885 - 2018-01-11
- FDA Inspection 985227 - 2016-09-06
- FDA Inspection 952369 - 2015-12-03
- FDA Inspection 870796 - 2014-03-05
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