OTC Import Alerts Could Grow Due To PREDICT Requirements

PREDICT eventually will help low-risk importers because data will drive the system to not flag those firms, easing the import process. Firms should work hard to stay off the import alert list, which prompts closer scrutiny and can lead to delays.

Data requirements imposed by FDA’s Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting system could drive up OTC drug import alerts in 2013 as some firms struggle to comply, according to food and drug importation consultant Ben England.

PREDICT ranks import shipments' risk based on assessments including a product’s intrinsic risk, results from previous inspections of shippers and...

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