FDA 483 - Alcami Carolinas Corporation - January 31, 2025

An FDA inspection of Alcami Carolinas Corporation, a contract testing laboratory in Wilmington, NC, identified a significant deficiency related to their written calibration procedures. The procedures for instruments, apparatus, gauges, and recording devices were found to lack specific schedules, limits for accuracy and precision, and provisions for remedial action when limits are not met. This indicates a potential issue with the reliability and control of laboratory equipment.