This is a definitive report.No further information can be obtained.This case report was received on sep 23, 2019 from the fda as mw5089675 dated sep 16, 2019.It was stated the affected lot number was 4x7207 in the actual letter.Review of the manufacturing records about 4x7z07 and 4x7z01 instead of 4x7207 were performed because there is no corresponding number.According to the results of investigation, there were no deviations or out-of-specifications found in the manufacturing process, the in-process testing, the release testing, and the environmental monitoring for lot# 4x7z07 and 4x7z01.
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