Preliminary analysis: · stock review: we proceed to review the stock of this product code and lot number and verifies that to date there are (b)(4) available.· quantity produced / imported: a total of (b)(4) of the reported batch were manufactured.(b)(4).Background: the claims database was reviewed and it was confirmed that there is no report related to this product code and lot number.Batch record: the documentation corresponding to the production of the batch was reviewed and it was verified that the batch had a normal process, no deviations or alterations were identified during production.Analysis of the sample (s): the sample received was visually checked and it was possible to identify that the unit was without the sterilizing solution; this was caused by an anomaly in the manufacturing process, which is not detectable in the final control and affects a minimum percentage of the lots; for this defect a corrective action was created (b)(4).Conclusions: actions: no action is required, since the failure that caused the cause reported in the claim was corrected long before receiving this report.
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