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Torbeck to Probe Recall Data For Insights Into Root Causes

This article was originally published in The Gold Sheet

Executive Summary

FDA consultant to tease out root causes of previous recalls.

FDA Sept. 25 contracted with Torbeck and Associates, Evanston, Ill., for a one- to three-year inquiry into the root causes of drug recalls.

FDA's Center for Drug Evaluation and Research has logged a yearly average of 23 Class I and 185 Class II recalls over the past five years into its Recall Establishment System, the agency said in a Sept. 13 combined synopsis/solicitation.

However, the system "does not capture specific root cause information for each of these recalls," FDA said.

The contract is for a retrospective assessment of recalls based on a review of field alert reports, Drug Quality Reporting System reports, biologic product deviation reports, establishment inspection reports, consumer and industry complaints, and an annual drug testing program.

The work involves reviewing archived data and meta data, extracting critical independent factors and critical dependent outcomes into a database, using statistical analysis and risk assessment methods to establish potential cause-and-effect relationships, relating the risks to public health concerns, and performing "a risk priority analysis for potential proactive intervention."

The contract also involves presenting an analysis and summary of the findings, as well as providing statistical-based training to FDA staff.

Consultant Lynn Torbeck is a statistician who specializes in current good manufacturing practice statistics and their applications. He provides training and consulting services in areas such as process analytical technology, design of experiments, data analysis, out-of-trend and out-of-spec analysis and sampling plans ("The Gold Sheet," December 2006).

- Bowman Cox ([email protected])

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