FDA 483 - Nippon Fine Chemical Co., Ltd. - June 11, 2019

Nippon Fine Chemical Co. Ltd, a drug excipient and active pharmaceutical ingredient manufacturer in Takasago City, Japan, was cited for significant procedural deficiencies during an FDA inspection. Observations included inadequate investigation of out-of-specification results and deviation handling, failure to meet deadlines for annual product quality reviews, and insufficient qualification of major raw material suppliers. These issues indicate a lack of adherence to established quality system procedures.