Investigation summary: one actual sample without packaging and one needle were received by our quality team for evaluation.From the returned sample, the team observed a dry residue of an unknown solution in between the stopper rib.No abnormality was observed on the stopper, and the sample was subjected to leakage testing and passed the specification.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.At the assembly process, there is a mechanism control to check the stopper leakage.There is currently a daily quality assurance routine leakage testing inspection in place to check for syringe leakage.As the sample passed the leakage testing, the root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
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