Karen L Kosar
Visit Investigator ProfileInvestigation Details
Detailed Analysis
Karen L Kosar is extremely detail-oriented and meticulous, often focusing on the micro-level aspects of cleanroom hygiene and employee expertise. She is strict on sterilization processes and pays significant attention to the storage and release of drug products.
FDA auditor Karen L Kosar has shown a keen interest in comprehensive contamination prevention measures, effective drug sterilization procedures, and the strict conformance to drug product release specifications. She often points out inadequate employee training, which strongly indicates an emphasis on the importance of well-trained staff in ensuring procedure compliance. Kosar seems to be meticulous and demarcates an interest in micro-level details, specifically regarding the areas of environmental monitoring and stability testing programs.
Unlock Insights from 483s & Stay Audit Ready with FDA Tracker
Monitor FDA Six Systems, Analyse 483s with Observations, Investigators & Companies