Batch manufacturing records of nw3321/ b9006 was reviewed for any process deviation but no deviation was observed.Additional summary: 13 representative samples were received in intact condition.During visual evaluation, received products were found genuine.These samples were visually inspected for attribute defects like pseudo seal, pin hole, product in seal, press marks on pack but no such defects were observed.The sutures were physically inspected for any attribute defects like kinks, weak spots, broken piece, fray, brittleness, detached needles but no such defects were observed.The needles were also inspected for any attribute defects like bend, cracked barrel, fins but no such defects were observed in received samples.Five retain samples of the incident code and lot number were also retrieved for analysis.These packs of retain samples were visually inspected for attribute defects like pseudo seal, pin hole, product in seal, press marks on pack but no such defects were observed.The sutures were physically inspected for any attribute defects like kinks, weak spots, broken piece, fray, brittleness, detached needles but no such defects were observed.The needles were inspected for any attribute defects like bend, cracked barrel, fins but no such defects were observed.Finished goods record was reviewed for fg release parameters like diameter, tensile strength, needle pull value & extractable color at release and was found to meet the specification.From the above analysis it is evident that there was no issue related to the suture quality and processing of this incident lot.All the individual/average diameter values for complaint representative & retain sample were found meeting usp individual/average diameter specification requirement.This analysis shows that there was no issue related to processing of the lot.All the values are within the control limits.
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