Class II · Moderate risk Terminated
Simvastatin
Reason cGMP deviations
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Class II · Moderate risk Terminated
Simvastatin
Reason cGMP deviations
Class II · Moderate risk Terminated
Simvastatin
Reason cGMP deviations
Class II · Moderate risk Terminated
Simvastatin
Reason cGMP deviations
Class II · Moderate risk Terminated
Glimepiride
Reason cGMP deviations
Class II · Moderate risk Terminated
Glimepiride
Reason cGMP deviations
Class II · Moderate risk Terminated
Glimepiride
Reason cGMP deviations
Class II · Moderate risk Terminated
Ropinirole
Reason cGMP deviations
Class II · Moderate risk Terminated
Ropinirole
Reason cGMP deviations
Class II · Moderate risk Terminated
Finasteride
Reason cGMP deviations
Class II · Moderate risk Terminated
Montelukast Sodium Tablets
Reason cGMP deviations
Class III · Low risk Terminated
Dofetilide Capsules
Reason Failed Content Uniformity Specifications
Class II · Moderate risk Terminated
Jardiance
Reason Labeling: Label Mix-up
Class II · Moderate risk Terminated
Calcitonin Salmon Nasal Spray
Reason Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
Class II · Moderate risk Terminated
Clobazam Tablets
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Clobazam Tablets
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Alprazolam Tablets
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Alprazolam Tablets
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Alprazolam Tablets
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Alprazolam Tablets
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Heparin Sodium
Reason Subpotent Drug: low Anti-Factor IIa potency.
Class II · Moderate risk Terminated
Heparin Sodium Injection
Reason Labeling: Not elsewhere classified
Class III · Low risk Terminated
Colchicine Tablets
Reason Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
Class II · Moderate risk Terminated
Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Activator Concentrate
Reason CGMP DEVIATIONS