Investigation summary: two photos and one sample were received by our quality team for evaluation.From the photo, a visible layer of coating on the rubber stopper was observed.From the returned sample, the team observed visible lubrication residue on the rubber stopper.The sample was subjected to the silicone content test and was within 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.From the returned observed visible lubrication (silicone) residue on the syringe rubber stopper.The silicone which was the only liquid material spray on the syringe barrel in the syringe assembly process is for easy withdrawal of the plunger.The sample passed the silicone content test and within specification, therefore the root cause could not be determined.This incident has been added to our database of reported incidents.
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