The product complaint is any communication regarding the failure or defect in the drug product and / or its components (either real or perceived), to meet any of its specifications or standards of quality, purity, safety, identity, performance, potency. Examples of product complaints include, but are not limited to: the crack in the glass vial, the vial contents looked cloudy; in the package insert in the carton, the cap was missing; in the vacuum in the vial when inserting needle; the needle was dull; or the syringe plunger was stuck.
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