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FDA Inspection
•Mediana USA, Inc.•December 23, 2014

Mediana USA, Inc. – FDA Inspection, Dec 23, 2014

Record Details

This FDA Inspection record concerns Mediana USA, Inc., with an inspection on December 23, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company
Mediana USA, Inc.
Inspection Date
December 23, 2014
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 9d05f1e4-e58a-4324-a334-657152be059e

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
908058
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

2
  1. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  2. 21 CFR 820.198(e)Records of complaint investigation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Mediana USA, Inc.

1
DateClassificationOfficeProject area
May 28, 2010VAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Mediana USA, Inc.
  • FDA Inspection 664940 - 2010-05-28

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