Visual inspection of both processed and unprocessed filler confirm the complaint.While a color transition did occur, the signal color would be acceptable per our release criteria.Feedback received from both the production supervisor and production lead offered possible root caused such as poor laydown of indicator ink during the manufactured process, insufficient applied pressure of the printing plate during the manufacturing process and insufficient indicator ink within ink pen of the printing press.A batch record review for the past two years shows no non-conformances on file or additional anomalies of note.All processed retains demonstrated color changes that were within specification.Additionally, a 1 year complaint history review was performed on (b)(6) 2018 by (b)(6) and no confirmed complaints are on file for the failure mode.Based on the inability to show correlation between the suspect product's failure mode and internal documentation from lack of a lot number, additionally root causes may include product near or at end of shelf life and storage conditions at point of use resulting in compromise of chemical indicator.We are confident that this confirmed complaint is an isolated incident and is unlikely to recur.As no lot number could be provided, testing of factory retains could not be performed as a comparison against the testing of the suspect product and batch record/complaint review was limited to a 2 year review.A definitive root cause could not be established as a result.In an effort of good faith.Crosstex will replace the case of suspect product with the most current manufactured lot.
|