Stelis Biopharma Pvt. Ltd. – FDA EIR, Jul 19, 2022

An FDA inspection of Stelis Biopharma Limited, a manufacturer of sterile injectable drugs, was conducted from July 11 to July 19, 2022. This inspection, carried out under Compliance Program 7346.832 for drug manufacturing facilities, encompassed a comprehensive review of the company's Quality, Facilities & Equipment, Materials, Production, and Laboratory Control systems. Specific areas examined included change control, deviations, CAPA processes, out-of-specification investigations, laboratory equipment qualification, and analytical method validation. Following the inspection, a Form FDA 483, Inspectional Observations, was issued to the Associate Vice President of Quality Assurance. While the specific details of the observations are not enumerated in this report, the overall classification of the inspection was "Voluntary Action Indicated (VAI)." This classification signifies that although observations were made, the FDA does not intend to pursue regulatory action at this time, anticipating the firm's voluntary corrective measures. Stelis Biopharma management acknowledged the observations, committed to implementing necessary corrections, and agreed to submit a written response within fifteen business days.