FDA 483 - Pace Analytical Life Sciences LLC - July 10, 2025

Pace Analytical Life Sciences LLC in Morrisville, NC, received a Form 483 with two observations during a pre-approval inspection for Heparin Sodium Injection, USP. The observations primarily concern deficiencies in computer system controls, specifically the failure to maintain data backups and inadequate audit trail functionality for a Nuclear Magnetic Resonance instrument used in drug substance identification testing. These issues indicate potential risks to data integrity and product quality.