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Undeclared wheat, milk, and soy (from soy lecithin) from sub-ingredients.
Undeclared milk and/or eggs from sub-ingredients and/or Contains statement.
Misbranding of the ingredient the firm sells ( Passionflower Herb Extract )
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Lack of Assurance of Sterility.
Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
Failed Dissolution Specifications: low dissolution results
cGMP Deviations
Lack of Processing Controls.