An investigation was completed for this complaint by the assigned manufacturing site investigation team.The complaint summary of this investigation required rework.A corrective actions/preventive actions (capa) was raised, and an updated/corrected investigation summary has been completed in accordance with assigned capa.A supplemental mdr is being submitted to document the completion of investigation rework and final investigation; the complaint record will proceed to closure.Batch record review: lot 8a06770 was manufactured on 02/02/2018, in bodolay line, with a total of (b)(4) ea.Compliance engineer performed a batch record review on 09/30/2020, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct, system application product (sap) material id 1713148 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Photograph, video and/or physical sample evaluation: there is a photograph associated with this case and in it, the defect reported by the customer can be seen.No unused return sample has been received for this complaint.Conclusion summary of the related event: based on the results of the preliminary investigation, the batch record reviews were performed, and no discrepancies were found.No harm was reported from any of the complainants.A revision of the improvements made to the process was performed, and actions have been implemented for some of the defect types reported.In addition, a retraining in the tm-002 will be given to the quality personnel of the bodolay line, in order to reinforce the correct execution of the method 7, which indicates the outlines that the visual testing required to ensure that the primary packaging, secondary packaging and package printing are free from nonconformities by visual means.Furthermore, an ncr search conducted shows that no adverse trend was identified from january 2018 to august 2020 for this failure mode.The investigation associated with related event has been approved and is complete.No additional action is required, and this complaint will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number.Reporting site: 1049092.Manufacturing site: 9618003.
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