FDA EIR - Alcami Carolinas Corporation - September 26, 2025

An unannounced comprehensive surveillance inspection of Alcami Carolinas Corporation, an oral solid dosage drug manufacturer in Wilmington, NC, was conducted by the FDA from September 22 to September 26, 2025. The inspection, carried out under Compliance Program 7356.002 (Drug Manufacturing Inspections), focused on quality, facilities and equipment, production, materials, and partially on laboratory controls, ensuring adherence to Current Good Manufacturing Practices (CGMP) and the Food Drug and Cosmetic Act. At the inspection's conclusion, a Form FDA 483, Inspectional Observations, was issued with three significant findings. Firstly, the company's equipment cleaning and maintenance procedures were deemed inadequate to prevent cross-contamination, particularly concerning potent drug substances sharing manufacturing spaces and equipment. The environmental monitoring program lacked sufficient verification of cleaning effectiveness, and analytical methods for detecting active pharmaceutical ingredient (API) carry-over were not sensitive or specific enough. Secondly, raw material sampling procedures for powdered substances lacked adequate detail and proper techniques, as routine sampling relied on single-use scoops inserted superficially, rather than more comprehensive methods like sampling thieves for larger containers. Lastly, the company failed to implement operational practices necessary to prevent insanitary conditions during manufacturing. Alcami management acknowledged these observations and committed to providing a formal response within 15 business days, outlining their corrective actions.