Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your firm did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO **(b)(4)** aseptic processing area.
Passage 2Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO **(b)(4)** area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.
Passage 3Your firm failed to sterilize **(b)(4)** by routine sterilization cycles and protect from contamination by sterilizing **(b)(4)** on **(b)(4)** air lines/vents.
Passage 4Your firm failed to perform adequate routine environmental monitoring in the ISO **(b)(4)** area. Specifically, **(b)(4)** units are not monitored using meaningful environmental monitoring data to include surface, viable active air, or non-viable air samples inside the **(b)(4)** units.