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
Specifically, non-viable monitoring excursions obtained during machine parts assembly of more than *** or *** successive events within *** were
Viewing of the aseptic filling area is only available through real time and previously recorded videos. During this inspection reviewed
Specifically, the media fill operation used to re-qualify one of your technicians for sterile operations on 08/24/22 consisted of the
On Jul 26, 2023, observed a Microbiology technician use another technician’s sign in for the *** Particulate Matter system to
Your ISO 5 aseptic operators failed to demonstrate adequate aseptic technique. For example:
On July 11, 2023, two (2) of
Specifically, major production equipment used to manufacture *** dosage drug products is not appropriately cleaned and maintained to prevent contamination.