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FDA Inspection
•Uroplasty LLC•November 1, 2016

Uroplasty LLC – FDA Inspection, Nov 1, 2016

Record Details

This FDA Inspection record concerns Uroplasty LLC, with an inspection on November 1, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company
Uroplasty LLC
Inspection Date
November 1, 2016
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Yehualashet A. Gessesse (Company Rep)
View Company Profile

ID · 6a85e802-e99e-4c1d-a8ef-0e45ac348550

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
996501
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 803.50(a)(2)Individual Report of Malfunction

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Uroplasty LLC

3
DateClassificationOfficeProject area
January 24, 2020NAICenter for Devices and Radiological HealthCompliance: Devices
November 16, 2012NAICenter for Devices and Radiological HealthCompliance: Devices
October 27, 2008NAICenter for Devices and Radiological HealthBioresearch Monitoring
Other documents for Uroplasty LLC
  • FDA Inspection 1121343 - 2020-01-24
  • FDA Inspection 809572 - 2012-11-16
  • FDA Inspection 544391 - 2008-10-27

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