Manufacturing site evaluation: samples received: 1 open pouch.There are no previous complaints of this code/batch.There are no units in oem stock.We have received 1 open sample with the needle detached from the thread.Thread is still wound on the pack.Without any closed sample we cannot carry out a complete analysis.Needle attachment results conducted on samples before releasing the product fulfilled the requirements of the oem.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfils oem requirements.Remarks: the complaint is justified for isolated detached needle, but the conclusion is not corresponding according to the results of the in process control when this batch was manufactured.Final conclusion: the complaint is not corresponding (not justified).Corrective/preventive actions: not applicable.Us reporting agent notified on (b)(6)2014.
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