FDA 483 - V-Ensure Pharma Technologies Pvt. Limited - January 27, 2023

V-Ensure Pharma Technologies Pvt. Limited in Raigad, India, was issued a Form 483 following an FDA inspection from January 23-27, 2023. The inspection revealed a significant quality system deficiency related to the firm's failure to investigate and document unexplained discrepancies in manufacturing records. This indicates a serious lapse in the firm's quality control and record-keeping practices for drug manufacturing.