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Reason CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…
Reason CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…
Reason CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…
Reason CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…
Reason CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…
Reason CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…
Reason CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…
Reason CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…
Reason CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…
Reason CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…
Reason CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…
Reason CGMP Deviations: Released product should have been rejected.
Reason Labeling: Not Elsewhere Classified - Wrong NDC number
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Reason CGMP Deviations: lack of adequate release testing.
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.