The QMN Weekly Bulletin

The Devil You Don’t Know: FDA Issues Enforcement Action Based on Non-FDA Inspection

June 29, 2012

International cooperation between regulators is “taking off” — a trend that could limit the amount of duplicate inspections drugmakers face, a top CDER official says. While “mutual recognition” of inspections is not yet a reality, drugmakers shouldn’t expect the FDA to close its eyes to negative inspection findings from other regulators.

In one instance, the agency has even used another country’s inspection data to take regulatory action, Justina Molzon, CDER’s associate director for international programs, said at the Drug Information Association annual meeting. The FDA did not conduct its own independent investigation in this case, Molzon said.

On the flip side, if the FDA is aware that another agency, particularly the European Medicines Agency (EMA), has recently inspected a manufacturer or clinical trial and nothing major came up, that site would become a lower priority for the FDA’s in-house inspectors as they work toward a risk-based approach for inspections, Molzon added. 

The FDA is aggressively pursuing tighter controls for current good manufacturing processes, supplier quality managements and preapproval inspections.

If you didn’t know the EMA’s inspection of your plant may have red flagged the FDA, you may want to attend FDAnews’ Seventh Annual FDA Inspections Summit this Sept. 19-21 in Bethesda, Md.

This conference will give you the inside information, tips, resources and education you’ll need to pass any inspection, be it from the FDA, EMA or Australia’s Theraputic Goods Adminstration. Knowing their inspections might tip off one another, a fail-safe inspection will keep you off all the regulators’ radars. Attend this conference today.