FDA EIR - Integrated Commercialization Solutions LLC - September 13, 2018

An initial FDA inspection of Integrated Commercialization Solutions LLC (ICS), a drug labeler and distributor in Lockbourne, OH, was conducted on September 12-13, 2018. The inspection, guided by regulatory guidelines for drug process inspections and repackagers/relabelers (CP 7356.002 and CPGM 7356.002B), focused on ICS’s labeling operations across its Quality, Facilities and Equipment, Materials, Production, and Packaging & Labeling systems.

While no formal FDA-483 observations were issued, verbal discussions highlighted two key areas for improvement. First, discrepancies were noted in executed batch records, including an improperly dated handwritten correction on a stock movement form, an incorrect label reconciliation count, and an unchecked verification on a line clearance form, all deviations from established internal procedures. Second, the inspection revealed a lack of documented quality checks for incoming labels; ICS primarily conducted checks during the labeling process rather than upon receipt.

Management for Integrated Commercialization Solutions LLC acknowledged these observations and committed to implementing immediate corrective actions. This includes rectifying the batch record errors and developing a procedure for comprehensive quality checks on all incoming labels to ensure proper reconciliation and compliance.