(b)(4).Manufacturing site evaluation: samples received: 10 unopened pouches.Analysis and results: there are no previous complaints of the same code-batch.Manufactured and distributed in the market (b)(4) units of this code batch.There are no units in stock.Tightness test to the samples received has been performed and the units are tight.Tested the needle attachment of all 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 oem requirements.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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