FDA Inspection
Palomar Pomerado HealthPalomar Pomerado Health – FDA Inspection, Feb 9, 2010
Record Details
This FDA Inspection record concerns Palomar Pomerado Health, with an inspection on February 9, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Palomar Pomerado Health
- Inspection Date
- February 9, 2010
- Product Type
- Biologics
View Company Profile
ID · 937dbfe2-241b-48dd-8197-bc91fe2e60b1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 643779
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
7- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 50.24(a)(6)No determination that IC procedure/document were approved
- 21 CFR 50.24(a)(2)No determination that obtaining IC wasn"t feasible
- 21 CFR 50.24(a)(3)Prospect of direct benefit not determined
- 21 CFR 50.24(a)(1)IRB failed to find/document required conditions
- 21 CFR 50.24(a)(7)Additional protections of rights and welfare
- 21 CFR 56.109(c)(2)Exception from informed consent; emergency research
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Other FDA inspections of Palomar Pomerado Health
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 8, 2015 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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