FDA 483 - Pace Analytical Life Sciences LLC - July 10, 2025
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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.
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ID · 3517a1a0-a806-4081-a133-ff9ee57c03b3