FDA 483 - Keystone Industries - December 21, 2022

Keystone Industries in Gibbstown, NJ, was cited for two significant issues during an FDA inspection from December 15-21, 2022. The firm failed to perform elemental impurity testing for finished drug product batches and did not follow its own procedures for placing products on stability studies. These deficiencies indicate a lack of adherence to quality control and testing requirements for drug products.