FDA 483 - Alcami Carolinas Corporation - October 29, 2021

An FDA inspection of Alcami Carolinas Corporation in Charleston, SC, a drug manufacturer, revealed four significant observations. The firm was cited for inadequate validation of sterilization processes, failure to calibrate instruments at suitable intervals, not following test procedures for pyrogens, and improper handling of microbial identification samples. These issues indicate deficiencies in the firm's quality control and manufacturing practices for sterile drug products.