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Nippon Fine Chemical Impedes FDA Inspectors, Gets Warning Letter

Oct. 12, 2016

Nippon Fine Chemical impeded a December 2015 inspection, the FDA said in a warning letter that claims employees blocked access to certain areas, refused to provide documents and prevented inspectors from taking photos.

During the inspection of the facility in Japan, the quality control manager of the plant directed employees to stand shoulder-to-shoulder, barring the investigators’ access to portions of the laboratory and the equipment used to analyze drugs.

Additionally, the firm refused to provide records of complaints made by customers, including complaints of bottles of drugs containing glass, hair, cardboard, metal, discolored product and a spider. Nippon Fine Chemical also refused to let investigators take photos of the apparatus used to manufacture drugs.

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