FDA EIR - NOVA LABORATORIES LIMITED - March 12, 2019

Nova Laboratories Limited underwent an FDA inspection from March 4 to March 12, 2019. Conducted under the *Inspection of Biological Drug Product* compliance program, the Level 1 inspection evaluated the company's contract manufacturing operations, focusing on its Quality, Production, Laboratory Control, and Material Systems. The inspection identified two main objectionable conditions. The first observation highlighted inadequate investigations into batch failures, specifically a failure to extend investigations to all potentially affected batches after an incorrect calculation was identified. Additionally, a deviation investigation for a high visual inspection reject rate lacked a definitive root cause and did not include identification of observed particulates, and the overall visual inspection reject rate for certain products lacked scientific justification. The second observation concerned deficiencies in establishing the reliability of component supplier reports. Full testing of raw materials used in manufacturing was not performed to confirm supplier analyses, and there was no written procedure for qualifying supplier test results at defined frequencies. Nova Laboratories' management acknowledged these findings and committed to implementing a comprehensive vendor qualification program that will include full testing to verify supplier Certificates of Analysis until suppliers are fully qualified. Corrective actions from a previous 2017 FDA inspection were verified as completed.