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FDA Inspection
•Cornell LLC•January 3, 2018

Cornell LLC – FDA Inspection, Jan 3, 2018

Record Details

This FDA Inspection record concerns Cornell LLC, with an inspection on January 3, 2018, issued by the Center for Devices and Radiological Health, covering devices.

Company
Cornell LLC
Inspection Date
January 3, 2018
Product Type
Devices
Office
Center for Devices and Radiological Health
People
  • Michelle J. Glembin (Company Rep)
  • Suzanne M. Crotty (Issuing Officer)
View Company Profile

ID · 84b635f5-bcb2-4e8a-bed4-82f2fbafecde

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1037045
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 820.20(e)Quality System Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Cornell LLC

1
DateClassificationOfficeProject area
December 6, 2018NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Cornell LLC
  • FDA Inspection 1079059 - 2018-12-06

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