FDA 483 - Alcami Carolinas Corporation - December 15, 2017

Alcami Carolinas Corporation, a sterile manufacturing facility in Charleston, SC, was inspected by the FDA. The inspection revealed deficiencies in the thoroughness of discrepancy investigations, particularly regarding out-of-specification reports. Additionally, the quality control unit's responsibilities and procedures were found to be inadequate, with issues in following SOPs for retesting, inconsistent analytical testing procedures, and unclear lyophilizer tagging procedures.