FDA: Sloppy NDAs May Signal GMP Issues, Other Problems

Sloppy NDAs may be considered red flags by the FDA, prompting regulators to take a closer look at GMPs and other company processes, Deborah Autor, director of the agency’s Center for Drug Evaluation and Research (CDER), said at FDAnews’ Fourth Annual FDA Inspections Summit.
 
The FDA’s new enforcement initiative will boost the number of warning letters, product seizures, injunctions and clinical investigator disqualifications going forward, and the speed of enforcement actions also is likely to increase, Autor said.

She noted the speed of two recent actions — a consent decree reached with KV Pharmaceutical four weeks after an inspection and a seizure of Caraco Pharmaceutical Laboratories products six weeks after an inspection. “I would like to see things move even faster than that,” she said.
Drug GMP Report