Root cause is difficult to determine due to no samples being provided for evaluation.However the most possible root cause may be, high blade, foreign matter on rollers, or sharp edges on number die.The following controls are in-place to mitigate ¿damage package¿ condition at (b)(4) site: incoming inspection procedures for aluminum foil rolls, including visual inspection for appearance.In-process inspections performed by packaging personnel, including for seal integrity and pouch integrity.¿high blade¿ sensor at ivers lee packaging line with ¿high blade¿ sensor challenge at the beginning of a new lot and per shift.Leak test at the beginning of a new lot and every 30 minutes until completion of the lot.Quality audits performed by quality inspectors, including for seal integrity and pouch integrity.Machine parts are inspected as part of the weekly machine pm.Device not returned.
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