FDA EIR - Novitium Pharma LLC - September 11, 2018

An FDA Pre-Approval Inspection (PAI) was conducted at Novitium Pharma LLC in East Windsor, NJ, from September 7 to September 11, 2018. The inspection assessed the facility's readiness for the approval of Abbreviated New Drug Application (ANDA) 211041, Nitisinone Capsules (2mg, 5mg, 10mg), under the regulatory framework of Compliance Program 7346.832, Drug Pre-approval Inspections. While no FDA Form 483 (Inspectional Observations) was issued, three significant areas of concern were discussed with firm management. These included a data integrity issue where an analyst re-processed API samples without a formal investigation, documenting the discrepancy only in a lab notebook. Additionally, in-process product labels lacked standardized instructions and a verification signature, potentially impacting material control. Lastly, two lots of Nitisinone API past their re-test dates were found with 'released' stickers in the warehouse, despite being recorded as quarantined in the paper inventory system, indicating a critical lack of synchronization between physical labeling and inventory records. Novitium Pharma LLC’s management acknowledged these findings and committed to implementing immediate corrective actions, including initiating proper investigations for data discrepancies, standardizing in-process labels to include verification, and ensuring accurate physical labeling and system synchronization for all material statuses.