FDA Inspection
UMass Memorial Medical CenterUMass Memorial Medical Center – FDA Inspection, Dec 11, 2015
Record Details
This FDA Inspection record concerns UMass Memorial Medical Center, with an inspection on December 11, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 11, 2015
- Product Type
- Devices
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ID · fe8310a0-efcf-4b90-97ac-2bf8b7ae1078
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 953635
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.18(a)Event files -- failure to establish and maintain
- 21 CFR 803.30(a)(2)Report of Serious Injury Within 10 Days
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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