FDA EIR - ImClone Systems, LLC - September 21, 2017

The FDA conducted a surveillance inspection of ImClone Systems, LLC, operating as Eli Lilly and Company, at its Branchburg, NJ facility from September 12 to 21, 2017. This inspection focused on active pharmaceutical ingredient manufacturing through biological fermentation and included specific follow-ups requested by the Center for Drug Evaluation and Research (CDER) concerning an out-of-specification result for a Lartruva process validation lot and a change in Portrazza storage conditions. The inspection found no significant deficiencies, and consequently, no Form FDA 483 Inspectional Observations were issued. During the inspection, several operational enhancements were discussed with management. These included reassessing aseptic processing to reduce contamination risk during Erbitux production, improving housekeeping in the microbiology laboratory to prevent false positive analytical results (which were corrected on-site), and addressing a potential security concern related to cell bank storage. The company also provided an expanded justification to CDER regarding the Portrazza storage condition change. The firm's Quality, Production, Laboratory Control, Building and Equipment, and Materials Systems were assessed as adequate, with discussed concerns being proactively addressed or slated for reassessment by management.