FDA EIR - Veranova LP - March 15, 2023

This FDA surveillance inspection of Veranova LP, an active pharmaceutical ingredient (API) manufacturer in West Deptford, NJ, occurred from February 6 to February 15, 2023. The inspection was conducted under Compliance Programs 7356.002, 7356.002F, and 7346.832, covering Quality, Production, Laboratory, Facilities & Equipment, Packaging & Labeling, and Materials systems. A Form FDA 483 was issued, citing two main observations. The first involved the quality unit's failure to fully investigate quality-related complaints. The second noted the absence of written procedures to justify reproducible and effective equipment cleaning. Further discussions included the firm's failure to assess potential long-term effects of manufacturing deviations on intermediate and API quality, and ensuring scientifically sound test procedures. Management pledged to correct all identified deficiencies. This inspection also confirmed that corrective actions for observations from a previous 2019 inspection, which covered deficiencies in equipment, quality, laboratory, and production systems, had been implemented.