A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.One unused cotton tip applicator with a content label was returned and visually inspected.Visual inspection confirmed the presence of blue markings on the cotton tip applicator.This type of defect is associated with an error in the supplier's manufacturing process.The root cause of the customer's complaint could be attributed to an error that occurred in the supplier's manufacturing process.The final goods product was manufactured in an environmentally controlled area (eca) that is routinely monitored.In addition, the manufacturing area operates in a controlled positive pressure environment and is continuously monitored to prevent entry of foreign material.The supplier has been notified of this complaint and will take appropriate actions as necessary.Complaints are continuously monitored to identify product and/or process areas where debris is occurring.In addition, routine training and awareness is conducted with all manufacturing associates to reinforce the importance of wearing proper personal protective equipment (ppe) and maintaining clean work areas.All lots are verified that all required inspections have been performed and all acceptance criteria are met prior to release.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending.The manufacturer internal reference number is: (b)(4).
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