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FDA Inspection
•St Luke's Regional Medical Center•December 11, 2012

St Luke's Regional Medical Center – FDA Inspection, Dec 11, 2012

Record Details

This FDA Inspection record concerns St Luke's Regional Medical Center, with an inspection on December 11, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
St Luke's Regional Medical Center
Inspection Date
December 11, 2012
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · d92de084-8884-4bf3-8fe8-e5906d65a91b

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
811102
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

1
  1. 21 CFR 606.160(a)(1)Person performing, test results, interpretation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of St Luke's Regional Medical Center

7
DateClassificationOfficeProject area
July 23, 2025NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
May 4, 2023VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
September 22, 2017NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
August 25, 2016VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
May 20, 2014NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 7 other inspections on the company page
Other documents for St Luke's Regional Medical Center
  • FDA Inspection 1276932 - 2025-07-23
  • FDA Inspection 1204351 - 2023-05-04
  • FDA Inspection 1028913 - 2017-09-22
  • FDA Inspection 983622 - 2016-08-25
  • FDA Inspection 879345 - 2014-05-20

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