FDA Inspection
Virginia Mason Medical CenterFDA Inspection 967426 - Virginia Mason Medical Center - April 15, 2016
Record Details
This FDA Inspection record concerns Virginia Mason Medical Center, with an inspection on April 15, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 15, 2016
- Product Type
- Devices
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ID · 822e4509-3d9f-4098-aa36-c68d02796b7e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 967426
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 803.18(b)(2)FDA access not permitted
- 21 CFR 803.18(b)(1)(i)Adverse events--all info not in file
- 21 CFR 803.30(a)(2)Report of Serious Injury Within 10 Days
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Virginia Mason Medical Center
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 11, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Virginia Mason Medical Center
- FDA Inspection 821793 - 2013-03-11
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