FDA EIR - Curia New Jersey, LLC - May 14, 2025

An FDA pre-approval inspection of Pace Analytical Life Sciences LLC (Pace NJ), a contract testing laboratory in Lebanon, NJ, was conducted from May 12-14, 2025. This unannounced inspection, falling under Compliance Program 7346.832 for Drug Preapproval Inspections, focused on the facility's microbiological testing capabilities for drug products, specifically endotoxin and sterility analysis, which are subject to the Food, Drug, and Cosmetic (FD&C) Act. The inspection covered readiness for commercial manufacturing, conformance to application, data integrity, and commitment to quality in pharmaceutical development. While no Form FDA 483 (Inspectional Observations) was issued during this inspection, several critical observations were discussed with management. Key issues included the absence of formal temperature and humidity mapping for the sample storage area, a lack of a defined naming convention for reanalyzed samples within the testing software, and inadequate tracking of laboratory instrument and equipment repairs. Furthermore, deficiencies were noted in plate technique during microbiological testing, and the Bacterial Endotoxin testing procedure lacked adequate detail. Pace NJ management verbally committed to implementing corrective actions for all discussed items. Specific actions include initiating a change control for temperature/humidity mapping, establishing a consistent naming convention for reanalyzed samples, improving repair tracking by integrating into the broader Pace QMS, retraining microbiologists on proper plate technique, and updating the Bacterial Endotoxin testing procedure to be more comprehensive. Memos were provided outlining these commitments.