FDA Inspection
Mills-Peninsula Health Services and San Mateo Medical CenterMills-Peninsula Health Services and San Mateo Medical Center – FDA Inspection, Jun 10, 2011
Record Details
This FDA Inspection record concerns Mills-Peninsula Health Services and San Mateo Medical Center, with an inspection on June 10, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 10, 2011
- Product Type
- Devices
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ID · 0e69e0ad-b907-42ee-b94b-486db0761737
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 735239
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
7- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 56.107(d)One non-affiliate member
- 21 CFR 56.107(c)One scientific and one non-scientific member
- 21 CFR 56.108(a)(2)More frequent reviews, verification of no changes
- 21 CFR 56.108(a)(4)Changes in approved research
- 21 CFR 56.110(b)(1)No more than minimal risk
- 21 CFR 56.108(a)(1)Initial and continuing reviews
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