FDA 483 - Suan Farma Inc. - September 26, 2025

Suan Farma Inc., an API re-labeler in Fair Lawn, NJ, received a Form 483 with significant observations. The inspection revealed critical deficiencies in drug substance storage conditions, including improper temperature/humidity control and lack of shipping condition documentation. Additionally, the firm failed to maintain appropriate controls over computer systems for environmental monitoring data and exhibited widespread issues with quality unit responsibilities, including missing deviation and change control records.