Results: bd received (b)(4) samples and additional photos from the customer facility for investigation.The samples and photos were evaluated and the customer's indicated failure mode for incorrect additive volume with the incident lot was observed.Additionally, (b)(4) retention samples were selected for evaluation, and the customer's indicated failure mode for incorrect additive volume was not observed in these.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: confirmed complaint.Bd was able to confirm the customer¿s indicated failure mode because the defect was evident in the testing of the returned samples.
|