Your film’s No. 04 Continuous Nonviable Pa1ticle Counter (NVPC), located near the *** conveyor area of *** Line *** is
On 25 August 2023, observed was ceiling port cover dislodged in Grade B space, directly over where Plant *** (Fill
Investigations opened to review environmental monitoring in which sterile drug products are filled are inadequate.
Your firm’s Quality Unit failed to ensure equipment is maintained and used within its validated state. For example:
Airflow visualization studies have not been performed for all interventions as required by procedure: SOP-MFP-00206, “Airflow Visualization Evaluation”, Version; 8,0,
On 25 August 2023, observed for plant *** RABS Fill Line *** Batch #*** was the transition of the ***
Specifically, inside the aseptic area used in the manufacture of *** Injection, ***mg/vial, a box (approximately ****), is outlined on
Specifically, Quality oversight is inadequate in that the aseptic processing areas are not designed to permit viewing through windows to
Your firm does not perform supplemental destructive testing to ensure the products are essentially free of visible particulates for ***
Specifically, cleaning procedures for the cleaning of *** RAB/RAB and the aseptic area do not contain enough detail to ensure