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Detailed Analysis
The inspector emphasizes ensuring that laboratory controls are sufficient and procedures are robust to maintain sterility and prevent microbiological contamination. He prioritizes the validation of written procedures for production and process controls, and places considerable importance on effective documentation.
The FDA investigator 'Unnamed In Provided Text' demonstrates a heightened focus on the various aspects surrounding production controls and sanitary conditions. This auditor seems to favor a meticulous approach, scrutinizing the procedural aspects of production and process controls, laboratory controls, as well as cleanliness and sterility within the manufacturing areas. He also shows particular concern for adequate documentation and validation procedures.
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