FDA Inspection
La Porte Health System IRBLa Porte Health System IRB – FDA Inspection, Apr 3, 2017
Record Details
This FDA Inspection record concerns La Porte Health System IRB, with an inspection on April 3, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 83aa9f0a-ffb1-4011-81ec-aeab2af69385
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1010694
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 56.108(c)Members present for review
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