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FDA quality inspections likely to be lengthy:

This article was originally published in Clinica

Executive Summary

Inspection times under the US FDA's Quality System Inspection Technique (QSIT) that goes into effect in January will take longer than the agency has predicted, according to the Health Industry Manufacturers Association (HIMA). FDA studies suggest that the average QSIT inspection should take 4.7 days. But the Draft Compliance Program Guidance Manual developed in preparation for the QSIT programme asks investigators not only to perform inspections under the quality system regulation but also to conduct inspections of adverse event reports, corrections and removals, tracking, electronic signatures and registration and listing. This is likely to substantially increase the length of time taken by the inspection, HIMA argues. The trade group also questions whether the criteria the FDA will use when it decides to recommend administrative or legal action is overly broad and could therefore result in warning letters after every inspection.

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