FDA EIR - Alcami Carolinas Corporation - September 26, 2025

An unannounced, comprehensive surveillance inspection of Alcami Carolinas Corporation, an oral solid dosage drug manufacturer and control testing laboratory located in Wilmington, NC, was conducted by the FDA from September 22 to 26, 2025. The inspection was performed under regulatory guidelines for Drug and Animal Drug Manufacturing Inspections (Compliance Programs 7356.002 and 7371.001). It thoroughly assessed the company's Quality, Facilities and Equipment, Production, and Materials systems, along with a partial review of Laboratory Controls.The inspection concluded with a "No Action Indicated" (NAI) classification, meaning no formal FDA Form 483, which details inspectional observations, was issued. However, three items were discussed with the firm during the closeout meeting. One specific point raised involved a 2018 revalidation of a [redacted equipment/process], where a temperature chart was missing. While no official regulatory actions were mandated, the discussion of these findings implies an expectation for the company to evaluate and address these points to maintain consistent adherence to Good Manufacturing Practices. This inspection followed a Pre-Approval Inspection conducted in February 2021, which did not include a general cGMP review.