483
Novartis Pharmaceuticals CorporationFDA 483 - Novartis Pharmaceuticals Corporation - December 09, 2022
Record Details
Novartis Pharmaceuticals Corporation in Morris Plains, NJ, was cited for significant deficiencies during an inspection related to the manufacturing of Kymriah product. Observations included recurring mold contamination in aseptic processing areas, continued use of primary packaging with foreign particulate matter, and unapproved manufacturing procedures. The firm also failed to adequately qualify equipment, maintain proper cleaning procedures, and conduct thorough investigations for out-of-trend results and process deviations.
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ID · b1680319-d6ed-404f-97d8-29d30a5966c6