(b)(4).Manufacturing site evaluation: samples received: 3 unopened pouches.Analysis and results: there are no previous complaints of this code batch.Manufactured and distributed (b)(4) units of this code batch.There are no units in stock.Received three closed samples.Tightness test to the samples received has been performed and the units are tight.Tested the knot pull tensile strength of the samples received and the results fulfill the oem requirements.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill the requirements.Remarks: when working with monomax suture material, great care should be taken to avoid any crushing or crimping damage of the monofilament by instruments such as forceps or needle holders.Final conclusion: although the results of the samples received fulfill the oem specifications, note of this incident is 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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