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FDA Finds QSR Breaches at South Korea’s Infopia

FDA Finds QSR Breaches at South Korea’s Infopia
An FDA inspection at Infopia in Anyang-si, South Korea, has found Quality System Regulation violations in the firm’s manufacturing of several glucose and lipid devices.  

By Jim Dickinson

An FDA inspection at Infopia in Anyang-si, South Korea, has found Quality System Regulation violations in the firm’s manufacturing of several glucose and lipid devices.

A recently released warning letter from July 10 says specific violations included the following:

  • Failing to verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished product.
  • Failing to ensure that when results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedure.

Infopia was told to take prompt action to correct the violations and to respond with a list of specific steps taken, documentation of each step, and a timetable for completion.

Jim Dickinson is MD+DI's contributing editor. 

[image courtesy of KIBSRI/FREEDIGITALPHOTOS.NET]

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