FDA 483 - Mankind Pharma Limited - April 13, 2023

Mankind Pharma Limited, operating a control testing laboratory in Gurugram, Haryana, India, was subject to an FDA inspection from April 11 to April 13, 2023. The inspection resulted in a Form FDA 483, outlining two primary observations related to the firm's quality control practices.

The first observation cited issues with the scientific justification of Out-of-Specification (OOS) laboratory investigations. For example, investigations into OOS results for raw material particle size distribution and drug substance system suitability lacked substantiated root causes. Conclusions were often made without sufficient supporting evidence, analyst confirmation, or experimental verification, leading to invalidation of OOS results without proper manufacturing investigations. This suggests potential deficiencies in the thoroughness of the company's deviation management and root cause analysis.

The second observation concerned the inadequate qualification of laboratory equipment and instruments for their intended use. The FDA noted that the Performance Qualification (PQ) for several critical instruments, including a Surface Area Analyzer, ICP-MS, Particle Size Analyzers, and PXRDs, consisted solely of calibration. There was insufficient documentation to demonstrate that specifications, requirements, or guidelines were properly considered in the design of these qualifications. This indicates a gap in ensuring equipment reliability and data integrity.

These observations highlight areas where Mankind Pharma Limited needs to strengthen its adherence to Good Manufacturing Practices, particularly in laboratory controls and equipment qualification. The company is expected to provide a comprehensive response detailing corrective and preventive actions to address these findings and ensure compliance.