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FDA Inspection
•St Lukes Hospital and Health Network•April 11, 2013

St Lukes Hospital and Health Network – FDA Inspection, Apr 11, 2013

Record Details

This FDA Inspection record concerns St Lukes Hospital and Health Network, with an inspection on April 11, 2013, issued by the Center for Devices and Radiological Health, covering devices.

Company
St Lukes Hospital and Health Network
Inspection Date
April 11, 2013
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 95219495-d2d0-4688-b107-a5c0e4f8c49a

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
826821
FDA center
Medical Devices & Rad Health
Project area
Bioresearch Monitoring

FDA Citations

3
  1. 21 CFR 56.115(a)(5)List of members
  2. 21 CFR 56.115(a)(2)Minutes of IRB meetings
  3. 21 CFR 56.108(a)(1)Initial and continuing reviews

Full citation text and observation details available on the Dashboard.

Other FDA inspections of St Lukes Hospital and Health Network

2
DateClassificationOfficeProject area
June 30, 2025NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
October 9, 2018NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
Other documents for St Lukes Hospital and Health Network
  • FDA Inspection 1277982 - 2025-06-30
  • FDA Inspection 1069421 - 2018-10-09

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