FDA 483 - Curia New Jersey, LLC - September 21, 2023

An FDA inspection of Curia New Jersey, LLC's Control Laboratory in Lebanon, NJ, identified a significant issue regarding the absence of critical testing equipment. The firm failed to follow established test procedures because X-Ray Powder Diffraction (XRPD) equipment, necessary for testing drug substance polymorphic forms at release and during stability, was not available on site. This indicates a serious deficiency in quality control and laboratory operations.