Simone E Pitts
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Detailed Analysis
Simone E Pitts tends to approach inspections in a systematic and detailed manner, focusing on adherence to procedures, effective quality control, rigorous risk assessment, and contamination control. Emphasizing on solid aseptic field integrity and the importance of SOP compliance to ensure product safety and effectiveness.
FDA investigator Simone E Pitts demonstrates a strong inclination towards contamination control, scrutinizing manufacturing processes and quality control procedures. He exhibits meticulous attention to detail and follows a methodical approach deeply rooted in ensuring adequate testing, proper disinfectant dispensing, temperature control and sterilization. With a history of focusing on system qualifications, aseptic process validation, and proper procedure adherence, he has a reputation for placing a high premium on effective and comprehensive risk assessment and proper documentation.
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