Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
West-Ward Columbus
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
Failed Impurities/Degradation Specificattion
Failed Dissolution Specifications:
Failed Dissolution Specifications:
Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print.
Failed Impurities/Degradation Specification; 9 month stability