martes, 14 de julio de 2009

FDA gets tough on GMP failures

Some dietary supplement firms have repeatedly failed to meet new Good Manufacturing Practices.

The regulatory agency has requested a permanent injunction against three New Jersey firms that manufacture supplements and protein blends, which were found to not be following current GMP regulations.

FDA conducted three inspections at the facilities, and each time noted “deviations” from GMP standards, it said. These included manufacturing and storing products in “filthy” conditions, with FDA investigators discovering live and dead rodents, as well as rodent urine and feces in the facilities. In addition, the firms were manufacturing the products in conditions that may cause contamination with allergens. During one inspection, investigations found several of the companies’ products contained milk ingredients that were not declared on the labels. The companies also failed to clean processing equipment between batches, said FDA.

“The companies promised to make corrections, but they failed to do so,” said the agency, prompting it to request the US Department of Justice to file a complaint for permanent injunction. “The FDA will not tolerate companies that fail to provide adequate safeguards,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs.

FDA is in the process of stepping up inspections at supplement manufacturing facilities, after the second and largest round of companies were required to become GMP compliant last month. The final rule of the GMP legislation was passed last year in an effort to provide standards specific to supplements for purity, safety and legality in manufacturing. Big companies (over 500 employees) had to implement the new standards in June last year. Mid-sized firms (20-499 employees) were required to become compliant last month, while small firms (less than 20 employees) have until June 2010 to comply.


Aporte: Alejandra Lavín

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