H.6.Investigation summary: the customer complaint is for sixteen (16) vials with broken caps (post sample collection) from item 491452 lot number 3060223.Material 491452 is produced at the bd mebane, nc facility on a validated automated manufacturing line referred to as the shibuya vial filling line.The capper section of the shibuya vial filling line contains eight (8) capper heads, which caps the vials to a validated application torque controlled by servo motor.The capper is validated to inspect for application torque and unseated or missing caps.Vials that fail to meet inspection requirements (i.E., outside of the validated application torque) are rejected automatically after the capper section.To ensure that the capper remains in validated state, a quarterly preventive maintenance (pm) is established that is used to confirm accuracy of application torque for each of the eight (8) heads.The pm is performed by using a calibrated servo torque verifier that is compared against the shibuya cap application torque value.Production of material 491452 lot 3060223 started on 07mar2023.A review of the two (2) pm events that bracketed the production date identified that the results of the verification were acceptable.A total of (b)(4) kits (b)(4) vials) were produced and were inspection using ansi general level ii, single sampling, normal, at an aql of 0.65%.A total of (b)(4) vials were qc inspected prior to product disposition with a total of 0 defects observed.An additional (b)(4) vials were leak tested in a vacuum chamber during in-process testing and did not identify any leaking or cracked cap defects.The review of the manufacturing dhr for the lot number identified that it was complete and accurate with no indication of abnormal activities during manufacturing.The review of the bill of materials (bom) for 491452 lot 3060223 identified that raw cap lot number material 700030951 lot number 3017888 was used during the production.Raw cap item number 700030951 is inspected using ansi general level ii, single sampling, normal, at an aql of 0.65%.A review of the incoming inspection results for 700030951 lot number 3017888 identified 800 caps were inspected from each lot and passed the acceptance criteria with zero defects identified.A sample was not returned to the mebane, nc facility for evaluation.Although pictures were provided, the pictures did not contain any vials with the complaint defect.A visual retain analysis was performed on one clamshell (25 vials) from item 491452 lot 3060223.No cracked/broken caps were identified during the retain analysis.The complaint is not confirmed.H3 other text : see h.10.
|