To aid in the investigation of this issue, one (1) picture sample and three (3) physical samples were returned for evaluation by our quality team.Through examination of the samples, three (3) syringes were identified without the barrel labels.As the lot is unknown for this incident, a review of the production history records could not be performed.The material involved (10ml syringe) could be manufactured in six (6) validated lines.No quality notifications or second samplings have been reported from october 2021 to present that could have contributed to this defect.All of the plunger assembly and labelers have a vision system to detect any issues that may occur.If a syringe has no label, the rejection system must reject the syringe.If there is a failure in this rejection process, the station stops and the operator must resolve the issue.It is most likely that this incident resulted from an error in the double rejection station.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
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