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 smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area.
Passage 2Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces.
Passage 3your Fluorescein 2% Ophthalmic Solution was subpotent (lots # 01242025@**(b)(4)**, potency of 85.865% and 03272025@**(b)(4)**, potency of 76.1475%)
Passage 4your Semaglutide 2.5mg/mL Injection was subpotent (lot # 03042025@**(b)(4)**, potency of 79.876%) and your Tirzepatide 10mg/mL Injection was subpotent (lots # 01172025@**(b)(4)**
Passage 5you did not provide copies of these protocols and the corresponding new smoke studies
Passage 6you did not provide corrective actions addressing this deviation for failure to notify patients and prescribers when OOS’s were identified.
Passage 7Your responses did not identify or discuss the root cause(s) for the numerous sterility and potency OOS results for your drug products intended to be sterile.