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FDA Inspection
•Fivos, Inc.•August 4, 2014

Fivos, Inc. – FDA Inspection, Aug 4, 2014

Record Details

This FDA Inspection record concerns Fivos, Inc., with an inspection on August 4, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company
Fivos, Inc.
Inspection Date
August 4, 2014
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · a86d0928-fa37-4de8-aeb0-fb6e049c8de1

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
890153
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

2
  1. 21 CFR 820.40Procedures not adequately established or maintained
  2. 21 CFR 820.20(e)Quality System Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Fivos, Inc.

2
DateClassificationOfficeProject area
November 7, 2019NAICenter for Devices and Radiological HealthCompliance: Devices
January 5, 2017NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Fivos, Inc.
  • FDA Inspection 1110192 - 2019-11-07
  • FDA Inspection 997578 - 2017-01-05

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