483
Keystone IndustriesFDA 483 - Keystone Industries - December 21, 2022
Record Details
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.
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ID · 999d4595-7f83-4e2a-9fa0-79a8fac23107