Closeout Letters Slow to Come After Warnings Are Resolved

FDA Commissioner Margaret Hamburg was right when she predicted last year that regulated companies that get warnings would really want a closeout letter. The trouble is that most of them aren’t getting the letters.

As of Nov. 5, only 4 percent of drugmakers and 7 percent of devicemakers that had received a warning letter since Hamburg’s new enforcement policy went into effect Sept. 1, 2009, have received a closeout letter, according to the FDA’s warning letter database.

And most of those who got a closeout had a long wait. On average, it took the Center for Devices and Radiological Health 179 days to issue a closeout letter after sending a warning letter, and the Center for Drug Evaluation and Research averaged 238 days. The delay can prove costly since an unresolved warning letter stalls related device approvals.
The GMP Letter