FDA EIR - Alcami Carolinas Corporation - March 15, 2018

An FDA inspection of Alcami Carolinas Corporation in Charleston, SC, took place from March 12-15, 2018. This abbreviated surveillance and pre-approval inspection followed a December 2017 inspection that identified deficiencies in reviewing unexplained discrepancies and adherence to quality control unit procedures. The current inspection focused on pre-approval coverage for a Biological License Application and an Abbreviated New Drug Application, alongside a systems-based review of Current Good Manufacturing Practices (cGMP) for Quality, Production, and Laboratory Control Systems, specifically for the firm's animal drug products.

While no Form FDA 483 (Inspectional Observations) was issued during this inspection, the FDA verbally conveyed several observations to management. These included inconsistencies in documenting deviations within the required timeframe and a high number of supervisor-related deviations. Specific observations during an engineering batch filling noted operator practices regarding glove sanitization and material introduction into sterile areas, prompting an internal incident. The firm's procedure for reviewing inspection reject data also lacked a specified frequency.

Management acknowledged these concerns and committed to implementing corrective actions. The FDA reminded the firm of its ongoing responsibility for compliance, noting that uncorrected conditions could still lead to regulatory sanctions. Progress on observations from the prior December 2017 inspection was ongoing, with additional time needed for complete resolution.