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Barry A. Friedman, PhD LLC

FDA Regulatory Compliance for the Pharmaceutical, Biotechnology and Medical Device Arenas

NIPPON FINE CHEMICAL CO RECEIVES IMPORT ALERT AND WARNING LETTER FOR REFUSAL TO ADMIT

October 11, 2016 By Barry Friedman Leave a Comment

Nippon Fine Chemical recently received a Form FDA 483 (December 14, 2015), followed by an Import Alert (August 8, 2016) and a Warning Letter (Click Here) (September 26, 2016) for adulterated products that were produced  at their drug manufacturing facility, Nippon Fine Chemical Co., Ltd, located at 1-1, 5-Chome, Umei, Takasago City, Hyogo.  The FDA investigator documented that … [Read more...]

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