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

Medispray Laboratories Private Limited underwent an FDA inspection from January 14 to January 20, 2025, at its finished drug product manufacturing facility in Ponda, Goa, India. The inspection resulted in observations primarily concerning the firm"s quality system and adherence to good manufacturing practices. A significant issue identified was the lack of documented responsibilities and procedures for the quality control unit, or a failure to fully follow existing ones. Specifically, an in-process quality control test for a drug product batch showed an initial failure due to a disconnected sensor and failed setpoints on December 26, 2024. A subsequent retest passed, but there was no documented quality assessment, incident report, or investigation into the initial failure. Furthermore, the standard operating procedure for operating the testing meter did not address resampling for failed measurements caused by sensor disconnections. Another critical observation involved data integrity and access control. A standalone computer in the in-process room, used for operating software, had a shared login username and password accessible to multiple employees within the Quality Assurance and manufacturing departments. This practice compromises data integrity and accountability. These observations highlight the need for Medispray Laboratories to implement robust corrective actions. These actions should include revising and strictly following quality control procedures, ensuring thorough investigation and documentation of all test failures, and establishing secure, individual access controls for critical systems to maintain data integrity and compliance with manufacturing regulations.