Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your firm failed to perform adequate routine environmental monitoring. Specifically, your cleanroom certification consists of nonviable airborne particulate and viable airborne particulate sampling of locations surrounding your **(b)(4)** filling line, but does not include sampling within the critical area where aseptic processing occurs.
Passage 2Your firm failed to appropriately sterilize equipment located in the ISO 5 area. Specifically, your firm did not sterilize the stopper sorting bowl, supply hopper, and insertion station that come into contact with stoppers used in the production of injectable drug products.