FDA EIR - Catalent Indiana, LLC - October 18, 2019

Catalent Indiana, LLC, a contract manufacturer of sterile pharmaceuticals, medical devices, and therapeutic proteins, underwent an FDA Pre-Approval and cGMP inspection from October 7-18, 2019. This inspection, conducted under FY 20 Workplan obligations and Compliance Programs 7356.002 and 7346.832, specifically reviewed the readiness for commercial manufacturing of Teprotumumab for Intravenous Infusion (BLA-761-143). The FDA issued a five-item Form 483, Inspectional Observations, citing several issues. Violations included the inadequate storage conditions for drug products due to a misplaced temperature monitoring probe and insufficient documentation of mapping studies. The firm also failed to follow written production and process control procedures, particularly regarding visual inspections, and did not establish or follow adequate procedures to prevent microbiological contamination, evidenced by residual glass in an ISO 5 area and improper aseptic cleaning techniques. Furthermore, equipment like the vial filling line's decking was not properly maintained to prevent pitting, and written maintenance procedures for this equipment were absent. A verbal observation was also given for the failure to perform complete method transfers for all analytical tests of the Teprotumumab drug product. Catalent management acknowledged the observations, began corrective actions during the inspection, and committed to addressing the remaining issues immediately with a written response. The FDA reminded the firm of its responsibility to adhere to the FD&C Act to avoid potential enforcement actions.