FDA EIR - Alcami Carolinas Corporation - January 29, 2019

An FDA inspection of Alcami Corporation, a contract manufacturer of solid oral dosage drugs and control testing facility located in Wilmington, North Carolina, took place from January 23 to January 29, 2019. The inspection assessed the firm's adherence to current Good Manufacturing Practices (cGMP), aligning with Compliance Program 7356.002, Drug Manufacturing Inspections, which falls under the Food Drug and Cosmetic Act's adulteration provisions. While the inspection concluded without the issuance of a Form FDA 483 (Inspectional Observations), certain systemic gaps were discussed with management. These included incomplete cleaning validation for a tablet press, as the feed frame was initially omitted from swabbing and testing. Concerns also arose regarding cleaning swab procedures being conducted without a fully validated recovery method for specific equipment. Furthermore, a lack of comprehensive user access lists for certain manufacturing equipment, particularly a tablet press, was identified. Alcami's management acknowledged these findings, stating that the firm had already begun assessing these areas. The company committed to implementing ongoing corrections and continuous improvements to resolve the identified issues, demonstrating a cooperative approach to addressing the FDA's observations.