OMB Individually Reported

SCANS Facility Role Predictor

Low riskExact public inventory row

Description

The AI was used to identify facilities that are either Active Pharmaceutical Ingredient (API) or Finished Dosage Form (FDF) manufacturers that were either missed or misclassified in regulatory tracking systems.

Detailed example

The output is a classification of Non-manufacturer, API, FDF, or API\FDF

AI / analytics pattern

Natural Language Processing: AI that processes, interprets, and shares information in human language.

Automation level / stage

c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.

Expected benefit

Successfully identified previously missed facilities without manually reviewing documents, improving FDA's ability to maintain comprehensive oversight of the drug manufacturing supply chain

Controls / human review

ATO: No; PIA: Not published

Data needed

We used 356H documents, which are vendor submitted documents describing facilities used in the production of a drug product.