Dhr review was performed on the lot number 6308948: the product was manufactured on afa line 6 from november 8, 2016 thru november 12, 2016 packaged on packaging line 11 from 11 from november 11, 2016 thru november 14, 2016.Review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Received two iag 14ga units from lot number 6308948.Package was partially opened, but this is the basis of the complaint.The product characteristics require a minimum of 1/8¿ seal width with adhesive transfer from the top web paper to the bottom web film.This characteristic was met.The key variables that affect the packaging seal are seal transfer/width and top web adhesive presence.Both of these variables were included in the investigation.The defect stated in the description of the complaint was confirmed with both returned packages was partially open at the bottom of the blister pack.Even though the packages were received partially opened, all the process characteristics that directly influence the seal were observed to be within specification.No anomalies were found.Bd supplier oliver-tolas (ot) 29lp uses a standard reinforced paper that is common to many other suppliers, but the adhesive type and application is specific to oliver-tolas.There is sufficient evidence to demonstrate the ot material or adhesive application is the root cause.(b)(4) was opened to investigate the package seal integrity complaints and implement corrective actions.
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