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FDA Inspection
•New York Presbyterian Hospital Weill Cornell Medical Center•December 10, 2015

New York Presbyterian Hospital Weill Cornell Medical Center – FDA Inspection, Dec 10, 2015

Record Details

This FDA Inspection record concerns New York Presbyterian Hospital Weill Cornell Medical Center, with an inspection on December 10, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company
New York Presbyterian Hospital Weill Cornell Medical Center
Inspection Date
December 10, 2015
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 9e08c28a-5437-4e4a-b773-ff11614f293f

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
952342
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

2
  1. 21 CFR 803.30(a)(1)Report of Death Within 10 Days
  2. 21 CFR 803.17Lack of Written MDR Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of New York Presbyterian Hospital Weill Cornell Medical Center

2
DateClassificationOfficeProject area
December 11, 2017Not classifiedNew York District Office
December 12, 2016Not classifiedNew York District Office
Other documents for New York Presbyterian Hospital Weill Cornell Medical Center
  • FDA Inspection 1035779 - 2017-12-11
  • FDA Inspection 994718 - 2016-12-12

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