FDA EIR - Alcami Carolinas Corporation - August 09, 2019

An FDA inspection of ALCAMI CORPORATION, a contract manufacturer and testing laboratory for prescription human and animal oral solid dose products, was conducted from August 5-9, 2019, in Wilmington, NC. This routine inspection, performed under the Animal Drug Manufacturing Inspections regulatory framework (Compliance Program 7371.001), focused on Quality, Facilities & Equipment, and Laboratory Control systems. The inspection concluded with a "No Action Indicated" (NAI) classification, meaning no formal FDA Form 483 was issued.

However, three verbal observations were discussed with management. Firstly, in the Facilities and Equipment System, discoloration on a production area filter housing required painting, and a work order was immediately initiated. Secondly, within the Quality System, the firm's practice of documenting minor incidents via memorandums, rather than integrating them into the main deviation system, raised concerns about consistent tracking and trending. Also, redundant weight checks for transferred materials were identified as potentially leading to variability, and the firm agreed to assess this practice. Lastly, for the Laboratory Control System, the microbiology laboratory's UV lights showed residue, and a lack of a preventive maintenance program for ensuring adequate decontamination was noted. The firm subsequently revised the relevant procedure to clarify UV light use and decontamination. Alcami Corporation acknowledged its responsibility to comply with applicable regulations.