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FDA Seizes All Drugs From Generics Maker
Date:6/25/2009

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In May, the FDA inspected Caraco once again and found continued violations of good manufacturing practices.

"Caraco exhibited poor control of their raw materials used to make their products," David Jaworski, a consumer safety officer in FDA's Office of Compliance in the Center for Drug Evaluation and Research, said during the teleconference.

"Also we saw that the firm's tablet manufacturing processes had higher than normal variability, which we believe has not adequately been addressed. We have also observed poor decisions being made by the company's management who are responsible for the quality of the drug products being manufactured," he said.

The agency is looking to work with Caraco to correct the problems in its manufacturing process, Autor said.

"Our goal is to get Caraco up and running safely," Autor said. "Seizures often lead to major changes by companies that help them break a cycle of poor performance," she noted.

More information

For more information on recalled Caraco products, visit the U.S. Food and Drug Administration.



SOURCES: June 25, 2009, teleconference with: Deborah M. Autor, director, Office of Compliance, Center for Drug Evaluation and Research; David Jaworski, consumer safety officer, Office of Compliance, Center for Drug Evaluation and Research, both U.S. Food and Drug Administration


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