Chanle Oka Martin
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Detailed Analysis
Mr. Martin primarily focuses on the verification of complete records and robust testing procedures. He is likely to scrutinize the sterility processes, complaint handling procedures, and adverse drug experience reporting mechanisms.
FDA Investigator Chanle Oka Martin is particularly stringent when it comes to inspections, often focusing on the presence of robust procedures for sterility, component testing, complaint handling, and safety reporting. He emphasizes on the necessity of complete and detailed records, both for individual batches and master production controls. His consistent concerns also include adequate microbiological testing and the validity of sterilization processes.
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