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FDA Inspection
•Presbyterian Hospital Blood Bank•July 18, 2013

Presbyterian Hospital Blood Bank – FDA Inspection, Jul 18, 2013

Record Details

This FDA Inspection record concerns Presbyterian Hospital Blood Bank, with an inspection on July 18, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Presbyterian Hospital Blood Bank
Inspection Date
July 18, 2013
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 8f7324b0-607f-4f4f-bf89-b50e9cc3e58f

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
841949
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

2
  1. 21 CFR 606.100(c)Thorough investigations
  2. 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Presbyterian Hospital Blood Bank

6
DateClassificationOfficeProject area
July 24, 2024NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
January 23, 2019NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
March 30, 2017NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
March 11, 2015NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
April 29, 2011NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
View all 6 other inspections on the company page
Other documents for Presbyterian Hospital Blood Bank
  • FDA Inspection 1247869 - 2024-07-24
  • FDA Inspection 1079363 - 2019-01-23
  • FDA Inspection 1020801 - 2017-03-30
  • FDA Inspection 916671 - 2015-03-11
  • FDA Inspection 727932 - 2011-04-29

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