FDA 483 - Alcami Carolinas Corporation - March 15, 2018

An FDA surveillance and pre-approval inspection of Alcami Carolinas Corporation in Charleston, SC, took place from March 12-15, 2018. The inspection assessed the firm's readiness for commercial production of a Biological License Application (BLA) and an Abbreviated New Drug Application (ANDA) product. It also covered systems-based Current Good Manufacturing Practice (cGMP) for quality, production, and laboratory control, with a focus on human and animal sterile drug products. Significantly, no Form FDA 483 Inspectional Observations was issued at the conclusion of this inspection. However, FDA verbally highlighted two main issues during the closeout meeting: deviations were not consistently created within the firm's stipulated timeframe from discovery, and several deviations indicated a lack of adequate supervisory oversight. This inspection followed a December 2017 inspection which resulted in a Form FDA 483 for inadequate review of discrepancies and failures in quality control unit procedures. Alcami Carolinas Corporation's management acknowledged the latest concerns and committed to addressing them, with FDA reiterating the firm's responsibility for compliance to prevent potential regulatory sanctions.