(b)(4).Manufacturing site evaluation: samples received: 21 unopened pouches and 2 opened.Analysis and results: there are no previous complaints of this code-batch.Manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in stock.Thread surface in closed samples received after pulling out the threads from the packs is correct and the usual one.No defects have been found.Furthermore, sewing test on artificial skin tissue has been conducted with the sample received and fraying does not appear when pulling the thread through the tissue.Visual appearance is the usual one as can be seen on enclosed picture, before and after sewing test.Tested the needle attachment of the closed samples received and the results fulfill the oem requirements.1.21 kgf in average and 0.84 kgf in minimum (ep requirements: 0.69 kgf in average and 0.35 kgf in minimum).Final conclusion: although the results of the closed samples received fulfill the oem specifications, note of this incident was taken in order to assess if new or additional actions are needed.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.
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