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FDA 483 Semantic Tagger

This repository contains the active taxonomy reference for tagging FDA 483 observations with a fixed set of quality and compliance tags.

What is here

  • flattened_quality_tag_taxonomy_v0_6.yaml: the active taxonomy, including allowed categories, values, aliases, revision history, and supporting notes

In plain language

Use the taxonomy file to see which tags are allowed and how they map to quality-system documents, records, controls, and processes.

What the taxonomy covers

  • FDA 483 observation content
  • drug, biologic, and medical-device quality topics
  • explainable matching to quality-system documents, records, controls, and processes

Repository status

This is a documentation repository. It retains only the README and the taxonomy YAML, and does not include an application, service, or build pipeline.

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FDA 483 regulatory observation tagging specification for drug, biologic, and medical device inspections.

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