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FDA Inspection
•The Hospitals of Providence-Memorial Campus•August 7, 2015

The Hospitals of Providence-Memorial Campus – FDA Inspection, Aug 7, 2015

Record Details

This FDA Inspection record concerns The Hospitals of Providence-Memorial Campus, with an inspection on August 7, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
The Hospitals of Providence-Memorial Campus
Inspection Date
August 7, 2015
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · b56d6617-becd-4bec-a90d-090fc6097f8e

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
941981
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

3
  1. 21 CFR 640.3(b)(3)Qualifications of donor - hemoglobin
  2. 21 CFR 606.160(a)(1)Concurrent documentation
  3. 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 The Hospitals of Providence-Memorial Campus

6
DateClassificationOfficeProject area
April 25, 2025Not classifiedDallas District Office
August 15, 2019NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
July 10, 2017NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
August 9, 2013VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
December 6, 2011NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 6 other inspections on the company page
Other documents for The Hospitals of Providence-Memorial Campus
  • FDA Inspection 1270066 - 2025-04-25
  • FDA Inspection 1102201 - 2019-08-15
  • FDA Inspection 1022640 - 2017-07-10
  • FDA Inspection 844120 - 2013-08-09
  • FDA Inspection 758687 - 2011-12-06

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