FDA Inspection
Lourdes Health System IRBLourdes Health System IRB – FDA Inspection, Feb 23, 2011
Record Details
This FDA Inspection record concerns Lourdes Health System IRB, with an inspection on February 23, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Lourdes Health System IRB
- Inspection Date
- February 23, 2011
- Product Type
- Devices
View Company Profile
ID · 3560cda1-9f54-4b22-8032-faf1318eb5fa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 715393
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
- 21 CFR 56.107(a)At least five members with varying backgrounds
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Other FDA inspections of Lourdes Health System IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 17, 2016 | NAI | Bioresearch Monitoring |
Other documents for Lourdes Health System IRB
- FDA Inspection 976401 - 2016-06-17
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