FDA 483 - Alcami Carolinas Corporation - March 28, 2025

An FDA inspection of Alcami Carolinas Corporation in Morrisville, NC, resulted in a Form 483 with four observations. The firm was cited for significant deficiencies in its quality control unit procedures, inadequate written procedures for equipment cleaning and maintenance, and a lack of a written program for drug product stability testing. Additionally, the company failed to establish appropriate time limits for various production phases to ensure drug product quality.