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FDA Inspection
•Pinook USA, LLC•May 13, 2015

Pinook USA, LLC – FDA Inspection, May 13, 2015

Record Details

This FDA Inspection record concerns Pinook USA, LLC, with an inspection on May 13, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company
Pinook USA, LLC
Inspection Date
May 13, 2015
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 9719bb64-3747-4b4d-8e66-633335c52cb7

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
927022
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

Other FDA inspections of Pinook USA, LLC

3
DateClassificationOfficeProject area
December 2, 2014OAICenter for Devices and Radiological HealthCompliance: Devices
March 1, 2013OAICenter for Devices and Radiological HealthCompliance: Devices
February 24, 2012OAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Pinook USA, LLC
  • FDA Inspection 904825 - 2014-12-02
  • FDA Inspection 821133 - 2013-03-01
  • FDA Inspection 769446 - 2012-02-24

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