Where do we start? seemed to be the gist of an FDA warning letter to Ningbo Smart Pharmaceutical, a Chinese API supplier who reported clean inspections on batches of raw materials –which were easy to fudge because the inspections were never done.

Pharmalot has a good wrap-up of the warning letter:

“It is essential that your firm only report results to customers when you have actually performed the analysis,” the FDA writes in reference to what may be called API Manufacturing 101.
Of course, as Pharmalot points out, as an API supplier, Ningbo’s uninspected, unverified batches could be in any number of pharmaceuticals on U.S. shelves.

That’s why manufacturer accountability and regular audits of API suppliers is so crucial. As several presenters pointed out at the After Heparin conference, “you can’t test in quality”—especially if your API supplier isn’t testing to begin with.

The Drug Safety and Accountability Act, introduced last year, would help here too, requiring manufacturers to verify and audit their suppliers before contracting, and conduct regular audits via management plans the FDA can review. It would also require drugmakers to produce documentation on request of every entity used in making and transporting its medicines. Setting up such systems might mean manufacturers would keep suppliers like Ningbo under thumb–perhaps shrinking the opportunity or incentive to fake inspections or destroy documents.

The DSAA would give the FDA subpoena power to get better access to documents and witnesses, as well. Sen. Michael Bennet who introduced the bill has said that he would look into expanding the bill to cover FDA foreign inspections in a future version.

–Kate Petersen, PostScript blogger