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]