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By: DAVID SAVASTANO

Contributing Editor, Coatings World and Ink World, Coatings World and Ink World Magazine

Any incident that causes the drug product or its labeling to be mistaken for or applied to another article, bacterial contamination, a significant chemical, physical, or other change, deterioration in the distributed drug product, and failure of one or more distributed batches of the drug product to meet the specifications established in its application.

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