FDA EIR - Novitium Pharma LLC - May 09, 2018

An FDA pre-approval inspection was conducted at Novitium Pharma LLC in East Windsor, NJ, from May 2 to May 9, 2018. This inspection, following the regulatory framework for Drug Pre-approval Inspections, evaluated manufacturing processes, equipment, production, and analytical records for two Abbreviated New Drug Applications (ANDAs): Diazoxide Oral Suspension USP, 50 mg/mL, and another pending ANDA. While no FDA Form 483 (Inspectional Observations) was issued, the inspection identified several concerns discussed with company management. Key issues included potential cross-contamination risks associated with non-dedicated manufacturing equipment and incomplete cleaning validations for shared processing lines. The firm had not yet developed a comprehensive cleaning validation matrix based on product solubility and potency. Additionally, deficiencies were noted in Master Batch Records (MBRs), specifically that dispensing records only referenced internal material codes instead of full ingredient names, and mixing speed ranges were too broad to ensure effective process control. Novitium Pharma LLC was informed that the two ANDAs would be recommended for approval, subject to the FDA’s Center for Drug Evaluation and Research (CDER) final review. To address the identified issues, the company committed to revising MBR dispensing records to include ingredient names, tightening mixing speed controls and confirming them during process validation, completing product-specific cleaning validations before commercial manufacturing, and establishing a bioburden baseline. These actions are necessary to minimize contamination risks and ensure ongoing regulatory compliance.