Review of the complaint history showed no similar complaint reported.Review of the preprocessing, filling and packaging manufacturing batch records (mbrs) showed no anomalies that may have contributed to the complaint condition.A single normal level 1 inspection by attributes for particulate inspection was completed by qa for this product met specifications.Incoming components are verified to meet key design criteria via dimensional analysis and attribute inspection prior to disposition.The root cause cannot be determined.Potential root causes that could be associated with the complaint condition include, but cannot be confirmed: nonconforming bottle- this is highly unlikely as the bottle undergoes several.Inspections from filling and packaging in process checks.In addition, the bottle is subjected to several processes that require handling of the bottle by packaging operators, unable to confirm.Customer handling-unable to confirm.Shipping damage outside of organization control.A comprehensive evaluation was completed that included review of the compliant history, mbrs, and finished product testing.The review shows that the manufacturing processes were in a state of control.Based on acceptable mbr reviews, in-process and finished product inspection results, the lot continue to be acceptable.No further action is warranted at this time.The manufacturer internal reference number is: (b)(4).
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