(b)(4).Manufacturing site evaluation: samples received: 4 unopened pouches.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.Tested the needle attachment of the samples received and the results fulfill the oem requirements.A minimum of five samples would be preferred because is the minimum number of units that requires the oem requirement.Final conclusion: although the results of the samples received fulfill the oem specifications, note is taken of this incident 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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