Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Amgen
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Defective container: loose crimp defect, potential loss of container integrity.
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Lack of Assurance of Sterility: Potential cracks in glass vials
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.