FDA Officials Issue Warning Letter to Japanese API Manufacturer

FDA officials warned Japanese API manufacturer Nippon Fine Chemical Co. for refusing to allow FDA officials to inspect the company’s facility, located at 1-1, 5-Chome, Umei, Takasago City, Hyogo. In a warning letter dated Sept. 26, 2016, officials said “your drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment where the owner or operator has limited inspection and refused inspection.”

According to the letter, during the inspection a control manager told employees to stand “shoulder-to-shoulder” barring FDA investigators from entering sections of the laboratory and equipment. The warning letter also states that FDA reviewed complaints received about drugs from customers, including complaints that they contained glass, hair, cardboard, metal, product discoloration, and a black spider. FDA said, “your firm limited the inspection by refusing to provide FDA copies of these records.” FDA said a quality assurance manager at the facility also impeded the FDA inspector from taking pictures of machinery used to manufacture drugs for US distribution.

The firm was placed on Import Alert 99-32 on August 8, 2016. Until FDA can inspect the facility, the agency said it can recommend withholding approval of any new applications or supplements listing the company as a drug manufacturer. Additionally, shipments from the facility are subject to refusal of admission.