Executive Summary

At a recent workshop on inspection trends at the recent PDA/FDA joint regulatory conference held in Washington on Sept. 24 FDA official Edwin Rivera noted that in terms of a firm's investigation of out-of-specification (OOS) test results, "the concern is that once you are in the Phase 2 investigation of the OOS failure the emphasis should be on the investigation and trying to determine the root cause. Often times what we see during our inspection is that the companies are pretty quick to do a re-test and a re-sample. We at FDA say in the OOS guidance that once you are in the Phase 2 a true OOS investigation should place more focus on the investigation and trying to find a root cause.