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An out of specification investigation must be completed each time a laboratory test
to verify that the finished batch of dietary supplement meets established product specifications
Failure to meet any specification must be investigated by Quality Control
dietary supplements
Sufficient space should be given to avoid mix-ups and cross-contamination
13.0 - Warehouse Holding Requirements 111.23 An out of specification investigationYou must hold components and dietary supplements under appropriate conditions of temperature, humidity, and light so that their identity, purity, strength, and composition are not affected, and components, dietary supplements and labels in a manner that does not lead to their mix up, contamination, or deterioration