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

Medispray Laboratories Private Limited, a finished drug product manufacturer located in Ponda, Goa, India, was inspected by the FDA from January 14 to January 20, 2025. During this inspection, several critical observations were noted concerning the company's quality control systems.

Key violations included the lack of written and fully implemented procedures for the quality control unit. Specifically, an incident was observed where a quality control test result was improperly handled. On December 26, 2024, a measurement was stopped due to a sensor disconnection, and the initial measurement was marked as "Cancelled" with failed setpoints. Although a subsequent test passed, there was no documented investigation or quality assessment of the initial failure. Furthermore, the standard operating procedures did not address how to handle and re-sample failed measurements due to sensor disconnection.

Additionally, it was observed that a standalone computer used in the in-process room had a shared login, accessible to multiple employees across the QA and manufacturing departments, raising concerns about data integrity and security.

The FDA's observations highlight significant gaps in Medispray's compliance with regulatory standards, specifically in maintaining robust quality control procedures and ensuring data integrity. The company is required to address these issues by implementing corrective actions, including establishing comprehensive written procedures for quality control and securing computer system access to ensure compliance with FDA regulations.