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Company Gets Warning Letter for In-Process Testing

February 13, 2009
The FDA cites Sage Products in a warning letter for allegedly failing to re-evaluate an in-process test after finished product testing showed that the test was not detecting nonconformances in the production of suction tip catheters. Sage told the FDA in its response to the Form 483 that it had updated its corrective and preventive action standard operating procedures to assess whether the corrective action would affect validated machine settings or its sampling plan, the agency says.
The GMP Letter