FDA EIR - Unimed Pharmaceuticals, Inc. - February 14, 2023

Unimed Pharmaceuticals Inc., a manufacturer of human drug products, including sterile solutions and liquids, underwent a surveillance Good Manufacturing Practice (GMP) inspection by the FDA from February 6 to February 14, 2023. The inspection focused on sterile liquid products for the US market, conducted under the compliance program for Sterile Drug Manufacturing Inspections (CP 7356.002A). Key systems reviewed included Quality, Facilities & Equipment, Materials, Production, and Laboratory Controls.

While no formal FDA-483 observations were issued, verbal observations were discussed with management. These included inadequate weight balance verification, employees not wearing sleeve covers during raw material weighing, unvalidated alternate cleaning procedures, insufficient visual qualification test samples for operators, and a lack of effectiveness checks after retraining for human error-related Out-of-Specification (OOS) events.

Unimed Pharmaceuticals Inc. management committed to implementing corrective actions for these verbal observations. The inspection concluded with a "No Action Indicated" (NAI) classification, meaning no further regulatory action is required by the FDA based on this inspection. No samples were collected, and no complaints or adverse events related to the covered products were reported by the firm.