FDA: Sloppy NDAs May Signal GMP Issues, Other Problems
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.
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