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FDA Inspection
•Genesys Orthopedics Systems, LLC•April 2, 2012

Genesys Orthopedics Systems, LLC – FDA Inspection, Apr 2, 2012

Record Details

This FDA Inspection record concerns Genesys Orthopedics Systems, LLC, with an inspection on April 2, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company
Genesys Orthopedics Systems, LLC
Inspection Date
April 2, 2012
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · ca840dab-faf9-4225-bbcf-98ad9968e8b2

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
773496
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

Other FDA inspections of Genesys Orthopedics Systems, LLC

5
DateClassificationOfficeProject area
August 10, 2023NAICenter for Devices and Radiological HealthCompliance: Devices
January 16, 2020NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
September 8, 2017VAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
June 24, 2014NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
June 5, 2013NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Genesys Orthopedics Systems, LLC
  • FDA Inspection 1221419 - 2023-08-10
  • FDA Inspection 1116370 - 2020-01-16
  • FDA Inspection 1024529 - 2017-09-08
  • FDA Inspection 885278 - 2014-06-24
  • FDA Inspection 834819 - 2013-06-05

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