FDA inspectors don't usually have industry experience. One area that concerned the notified body auditors is that unlike the US, they conduct technical reviews during their ISO-type audits and review technical documents, Buffaloe added. This means that the auditors get into judgments regarding areas such as intended use, performance and compliance with standards. The training, of course, did not end in London. At the August session, FDA discussed how to prepare for an inspection and work on evidence development.
More work still lies ahead.
Each of the European auditors will be able to participate in a series of three inspections in Europe. These inspections started in September. With first inspections, the European auditors will participate, but the FDA investigator will take the lead in conducting the inspection. We typically do inspections of foreign companies, and this will be done as part of our typical foreign inspection program. With the second phase, a European auditor will do the inspection while he or she is observed by the FDA investigator and evaluated.