FDA 483 - Exelead, Inc. - December 20, 2023

Exelead, Inc., a contract drug and biotech manufacturer in Indianapolis, was cited for numerous significant deficiencies during an FDA inspection. The firm failed to thoroughly investigate batch discrepancies, exhibited poor aseptic techniques, and had critical data integrity issues with manufacturing records. Additionally, the inspection revealed inadequate visual inspection processes, deficient environmental monitoring, poor complaint handling, and insufficient quality unit oversight, all of which compromise the quality and sterility of their drug products.