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The former is an indicator of quality materials and good manufacturing processes.
She said the agency had held up the imports because of issues related to compliance with F.D.A. requirements called good manufacturing processes.
The manufacturer, Centeon, a subsidiary of Rhone-Poulenc, in King of Prussia, Pa., stopped production voluntarily from January to September after drug agency inspectors found "very serious breaches of good manufacturing process," Dr. Epstein said.
Although the FDA issued a final rule establishing regulations to require manufacturers of dietary supplements to prove good manufacturing processes and to correctly label their ingredients,[56] the standardization of products such as St. John's wort with respect to the desired amount of potentially active ingredients is not carried out.
