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FDA Inspection
•Christus Spohn Hospital Corpus Christi - Memorial Campus•February 4, 2011

Christus Spohn Hospital Corpus Christi - Memorial Campus – FDA Inspection, Feb 4, 2011

Record Details

This FDA Inspection record concerns Christus Spohn Hospital Corpus Christi - Memorial Campus, with an inspection on February 4, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company
Christus Spohn Hospital Corpus Christi - Memorial Campus
Inspection Date
February 4, 2011
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 02b4b434-4ddc-41f1-beea-9cef043e9500

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
708648
FDA center
Medical Devices & Rad Health
Project area
Bioresearch Monitoring

FDA Citations

8
  1. 21 CFR 56.115(a)(5)List of members
  2. 21 CFR 56.108(c)Members present for review
  3. 21 CFR 56.115(a)(2)Minutes of IRB meetings
  4. 21 CFR 56.115(b)Access to records
  5. 21 CFR 56.107(e)Conflict of interest
  6. 21 CFR 56.111(b)Vulnerable subject safeguards
  7. 21 CFR 56.108(a)(1)Initial and continuing reviews
  8. 21 CFR 56.110(b)(2)Minor changes

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Christus Spohn Hospital Corpus Christi - Memorial Campus

1
DateClassificationOfficeProject area
February 1, 2013VAICenter for Devices and Radiological HealthBioresearch Monitoring
Other documents for Christus Spohn Hospital Corpus Christi - Memorial Campus
  • FDA Inspection 817839 - 2013-02-01

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