This document discusses manufacturing functions and controls to avoid blend-ups and cross contamination. It outlines safety measures like good air dealing with, segregated parts, and status labeling. Processing of intermediates and bulk solutions has to be documented and checks set set up to be sure

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If any main concerns needing correction are found, All those might be explained in a Form 483. At this time, you’ll have a chance to consider corrective actions. Commonly, FDA will only adjust an OAI inspection classification after a corporation implements extensive corrective and preventiv