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FDA Inspection
•Hoxworth Blood Center University of Cincinnati•September 8, 2025

Hoxworth Blood Center University of Cincinnati – FDA Inspection, Sep 8, 2025

Record Details

This FDA Inspection record concerns Hoxworth Blood Center University of Cincinnati, with an inspection on September 8, 2025, issued by the Cincinnati District Office, covering biologics.

Company
Hoxworth Blood Center University of Cincinnati
Inspection Date
September 8, 2025
Product Type
Biologics
Office
Cincinnati District Office
Person
  • Jennifer L. Sheehan (Issuing Officer)
View Company Profile

ID · 8038df8d-7227-494d-b19b-a3fd18d7acfb

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1281136
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued, view the record

FDA Citations

2
  1. 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
  2. 21 CFR 630.10(g)(1)Proof Of Identity

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Hoxworth Blood Center University of Cincinnati

7
DateClassificationOfficeProject area
September 28, 2023NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
September 4, 2019VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
May 17, 2017NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
April 20, 2015NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 26, 2013NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 7 other inspections on the company page
Other documents for Hoxworth Blood Center University of Cincinnati
  • FDA Inspection 1219457 - 2023-09-28
  • FDA Inspection 1101559 - 2019-09-04
  • FDA Inspection 1010941 - 2017-05-17
  • FDA Inspection 923265 - 2015-04-20
  • FDA Inspection 837514 - 2013-06-26

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