Lakshmi Narasimhan

Lakshmi Narasimhan takes a methodical approach, giving significant attention to the accuracy and completeness of documentation, the consistency of adherence to SOPs, and the effectiveness of quality control procedures. He is thorough in examining the alignment between submitted information and actual manufacturing processes.

Lakshmi Narasimhan is a detail-oriented FDA auditor who focuses on discrepancies in submission information vs manufacturing processes, inadequate quality assurance policies, inadequate handling of in-process samples, lack of quality oversight in QC testing procedures, inconsistent and unclear OOS procedures, inadequate microbial control, inadequate bioburden sampling during drug product manufacturing, and delays and inadequate justifications in deviation handling. He prioritizes thorough documentation and stringent adherence to standard operating procedures.