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•Conod Medical Co., Limited•July 30, 2015

FDA 483 - Conod Medical Co., Limited - July 30, 2015

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Record Details

Conod Medical Co., Limited, a medical device manufacturer in Changshu City, China, was cited with two observations during an FDA inspection. The observations concern inadequate process validation for sterile packaging and insufficient procedures for acceptance activities related to bubble leak testing for urine bag devices.

Company
Conod Medical Co., Limited
Inspection Date
July 30, 2015
Product Type
Device
Office
Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person
  • Leighton K. Ngai (investigator)
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ID · 94d3908b-c1a2-4b13-b056-1c5ccd656c22

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