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Business

Japanese firm prevents FDA access

by Jean-François Tremblay
October 17, 2016 | APPEARED IN VOLUME 94, ISSUE 41

FDA issued a warning letter to Nippon Fine Chemical after the company prevented agency officials from entering the quality-control lab of its plant in Takasago, Japan. The incident occurred in December 2015 when, according to FDA, “the quality-control manager directed employees to stand shoulder-to-shoulder, barring our investigator from accessing portions of the laboratory and the equipment used to analyze drugs for U.S. distribution.” During the inspection, the company didn’t allow FDA to copy customer complaint letters describing shipments that contained foreign objects including glass, cardboard, metal, and a spider. FDA has banned the company’s products from the U.S.

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