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FDA Finds QSR Breaches at South Korea’s InfopiaFDA 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.
November 4, 2014
1 Min Read
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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