Us reporting agent notified on (b)(4) 2014.Manufacturing site evaluation: samples received: 24 unopened pouches.There are no previous complaints of this code/batch.All packs received are tight.Tested the knot pull tensile strength of the samples received and the results fulfil the requirements of the oem.Knot pull tensile strength results before releasing the product fulfilled oem requirements.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfils oem requirements.Final conclusion: the complaint is not corresponding (not justified).Corrective/preventive actions: not applicable.
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