FDA EIR - Alcami Carolinas Corporation - February 18, 2021

An FDA Pre-Approval Inspection (PAI) of Alcami Carolinas Corporation in Wilmington, NC, was conducted from February 8-18, 2021. This inspection, guided by the compliance program for Pre-Approval Inspections, evaluated the firm's capability to manufacture and test specific FDA-regulated drug products for a New Drug Application (Capsules, Prompt Release). The assessment covered batch records, standard operating procedures, deviations, and equipment qualification. No FDA Form 483 (Inspectional Observations) was issued. However, three verbal observations were discussed with management. These included a missing temperature chart from a 2018 equipment revalidation, the absence of a compliance report for overdue filter preventive maintenance on the production HVAC system coupled with a 4.5-month delay in document sign-off, and the observation of rouging (corrosion) on valves in a controlled production area. Alcami Carolinas Corporation initiated voluntary corrective actions. They opened deviations for the missing chart and the compliance report, agreeing to address sign-off timeliness. An emergency work order was also issued and completed to correct the rouging before the inspection concluded, with management confirming these actions would be addressed for continued compliance.