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FDA Inspection
•Temple University Hospital - Jeanes Campus Blood Bank•June 18, 2010

Temple University Hospital - Jeanes Campus Blood Bank – FDA Inspection, Jun 18, 2010

Record Details

This FDA Inspection record concerns Temple University Hospital - Jeanes Campus Blood Bank, with an inspection on June 18, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Temple University Hospital - Jeanes Campus Blood Bank
Inspection Date
June 18, 2010
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · c461339d-a886-495f-8827-eee9192bebbc

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
668740
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

4
  1. 21 CFR 606.170(a)Adverse reaction - Maintenance of Reports
  2. 21 CFR 606.160(a)(1)Person performing, test results, interpretation
  3. 21 CFR 211.22(d)Procedures not in writing, fully followed
  4. 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 Temple University Hospital - Jeanes Campus Blood Bank

7
DateClassificationOfficeProject area
April 15, 2025Not classifiedPhiladelphia District Office
February 18, 2020NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
December 1, 2017NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
January 12, 2016NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 27, 2014NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 7 other inspections on the company page
Other documents for Temple University Hospital - Jeanes Campus Blood Bank
  • FDA Inspection 1269365 - 2025-04-15
  • FDA Inspection 1121001 - 2020-02-18
  • FDA Inspection 1035059 - 2017-12-01
  • FDA Inspection 958026 - 2016-01-12
  • FDA Inspection 868505 - 2014-02-27

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