Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Eugia US
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class I - Dangerous
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
CGMP Deviations
Class I - Dangerous
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Class I - Dangerous
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Presence of Particulate Matter
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Failed Stability Specification: Water determination was found not complying with specification.
Failed Dissolution Specifications
Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial