FDA 483 - Veltek Associates, Inc. - February 06, 2025

An FDA inspection of Veltek Associates, Inc. in Malvern, PA, a drug repacker/relabeler, identified a significant quality control issue. The firm failed to establish and document the accuracy, specificity, and reproducibility of analytical test methods used for releasing over-the-counter drug products. Specifically, the assay test for ethanol in DECON-HAND was not verified under actual testing conditions.