FDA EIR - Cerovene Inc. - February 08, 2017

An FDA pre-approval inspection of Cerovene, Inc., a prescription drug manufacturer located in Valley Cottage, NY, took place from January 26 to February 8, 2017. The inspection, conducted under CPGM 7356.002 and 7346.832, aimed to assess the firm's readiness for commercial manufacturing of NDA 209777, Oxycodone HCl Abuse-Resistant Immediate Release Tablets. Key findings led to an FDA-483 observation primarily concerning inadequate equipment qualification of the tablet coating machine. Cerovene failed to properly document critical details like core tablet weight, size, and appearance during performance qualification (PQ) studies. Moreover, the coating machine was not adequately challenged across the full operating range planned for commercial batch sizes during the qualification process. Further deficiencies were verbally communicated, including the quality unit's insufficient review of records, notably regarding outdated calibration certificates for qualification devices and inconsistencies in HPLC audit trails, such as unexplained "trial" injections and re-injections. The inspection also identified missing manufacturing and in-process sampling instructions in master batch records, and an inadequate system for tracking out-of-specification (OOS) results from system suitability test failures. Cerovene management acknowledged these observations, providing a written commitment to address the issues. The firm pledged to submit a formal response to the FDA-483 within 15 business days, conduct additional performance qualification for the coating machine, implement corrective and preventive actions (CAPA 2017-001) to enhance laboratory data control, and revise standard operating procedures for OOS tracking. The proposed corrective measures will be reviewed by the FDA's Center for Drug Evaluation and Research (CDER) and the Compliance Branch for adequacy.