Surface monitoring of the filling and stoppering machine is not performed in a timely manner following the completion of aseptic
On April 29, 2024, *** cleaning wipes packed and ready to be used for *** aseptic cleaning in the Grade
Your environmental monitoring (EM) of the ISO 5 Laminar Airflow Hood (LAFH) in Sterile Non-Hazardous Drug Suite and the ISO
On April 2, 2024 during post production manual cleaning of line *** RABS ID PR***RABS-001 used in the manufacture of
On 3/26/2024, we inspected *** vessel ***/MFG***V/648 in the line *** aseptic manufacturing equipment storage area. Vessel **/MFG***V/648 was documented
Specifically, disinfectant efficacy studies have not been performed for the ***, and the *** cleaning solutions used within your IS0-5
Specifically, your firm has no written procedures on what corrective actions are to be performed when aseptic areas have a
On 07/10/2023 and 07/12/2023, inspected the post assembly and/ or aseptic filling of *** mL batch *** respectively. Observed the
On August 9,2023 your technician (***) did not spray their gloves with a deactivating agent or change their gloves after
On August 18, 2023, your technician *** did not clean the ***, located *** the ISO 8 classified preparation room