FDA 483 - Medispray Laboratories Private Limited - January 20, 2025

Medispray Laboratories Private Limited, a finished drug product manufacturer in Ponda, Goa, India, was inspected by the FDA. The inspection revealed significant deficiencies in the firm's quality control unit, including a lack of written procedures and adherence to them. Specifically, issues were noted with in-process quality control testing data integrity, inadequate investigation of measurement failures, and shared login credentials for critical software.