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FDA: Enforcement Crackdown Is Moving Quickly

September 11, 2009
The FDA in the last year has employed a broad array of tools — a consent decree, drug seizures and an import alert for 30 generic drug products made at two Ranbaxy facilities in India — to accelerate its stricter enforcement campaign.

A June seizure of products from Caraco Pharmaceutical Laboratories occurred six weeks after an FDA inspection, Edwin Rivera-Martinez, chief of the international compliance branch in the Center for Drug Evaluation and Research’s division of manufacturing and compliance, said last month at the 14th Annual GMP by the Sea conference.

He also noted a March consent decree with KV Pharmaceutical that was signed four weeks after the FDA conducted an inspection. “Getting an injunction against a company in four weeks is relatively quick,” he said. The decree allows the company to resume production operations once its facilities are deemed compliant with current GMPs.
Drug GMP Report